Optima Coil System
The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and…
The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller. 5 Year Shelf Life
6manufacturers in China registered for this device type
255catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Suzhou Haowei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Balt USA, LLC, United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K200030 |
| Record published | 2020-02-28 |
| Record revised | 2021-10-05 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at a controlled room temperature in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OPTI0720HSFMX | Helical OptiMAX Soft – 7mm x 20cm | In distribution |
| PRES0310CXP10 | Complex 10 Xtra Pack 3mm x 10cm | In distribution |
| OPTI0202CSSMX | Complex OptiMAX Supersoft 18 – 2mm x 2cm | In distribution |
| PRES1343COM18 | Complex-18 13mm x 43cm | In distribution |
| OPTI2512BLK | 2.5mm x 10cm (Secondary Diameter x Length) | In distribution |
| PRES0101HXP10 | Helical 10 Xtra Pack 1mm x 1cm | In distribution |
| PRES0816CRG10 | Complex 10 Regular 8mm x 16cm | In distribution |
| PRES2265COM18 | Complex-18 22mm x 65cm | In distribution |
| OPTI2535HSSMX | Helical OptiMAX Supersoft – 2.5mm x 3.5cm | In distribution |
| OPTI0255CSSMX | Complex OptiMAX Supersoft – 2.5mm x 5cm | In distribution |
| OPTI0153HSSMX | Helical OptiMAX Supersoft – 1.5mm x 3cm | In distribution |
| PRES0930HRG10 | Helical 10 Regular 9mm x 30cm | In distribution |
| PRES0304HXP10 | Helical 10 Xtra Pack 3mm x 4cm | In distribution |
| OPTI1345CSFMX | Complex OptiMAX Soft – 13mm x 45cm | In distribution |
| PRES0356CXP10 | Complex 10 Xtra Pack 3.5mm x 6cm | In distribution |
| PRES0202CXP10 | Complex 10 Xtra Pack 2mm x 2cm | In distribution |
| PRES0204CPK10 | Complex 10 Pack 2mm x 4cm | In distribution |
| OPTI0407CSFMX | Complex OptiMAX Soft – 4mm x 7cm | In distribution |
| OPTI0210CSS10 | Complex Supersoft – 2mm x 10cm | In distribution |
| OPTI0417CSF10 | Complex Soft – 4mm x 17cm | In distribution |
| PRES0827COM18 | Complex-18 8mm x 27cm | In distribution |
| OPTI0650BLK | 6mm x 50cm (Implant Size) | In distribution |
| PRES0407CPK10 | Complex 10 Pack 4mm x 7cm | In distribution |
| PRES1240COM18 | Complex-18 12mm x 40cm | In distribution |
| PRES0410HXP10 | Helical 10 Xtra Pack 4mm x 10cm | In distribution |
| OPTI3515BLK | 3.5mm x 15cm (Implant Size) | In distribution |
| OPTI0410CSF10 | Complex Soft – 4mm x 10cm | In distribution |
| PRES0816CPK10 | Complex 10 Pack 8mm x 16cm | In distribution |
| PRES2065COM18 | Complex-18 20mm x 65cm | In distribution |
| PRES0724CPK10 | Complex 10 Pack 7mm x 24cm | In distribution |
| OPTI0509CST10 | Complex Standard – 5mm x 9cm | In distribution |
| PRES0153CXP10 | Complex 10 Xtra Pack 1.5mm x 3cm | In distribution |
| OPTI0517CSFMX | Complex OptiMAX Soft – 5mm x 17cm | In distribution |
| OPTI0306CST10 | Complex Standard – 3mm x 6cm | In distribution |
| PRES0208CXP10 | Complex 10 Xtra Pack 2mm x 8cm | In distribution |
| OPTI2525CSSMX | Complex OptiMAX Supersoft – 2.5mm x 2.5cm | In distribution |
| OPTI0315HSSMX | Helical OptiMAX Supersoft – 3mm x 15cm | In distribution |
| OPTI0412CSS10 | Complex Supersoft – 4mm x 12cm | In distribution |
| PRES0306CPK10 | Complex 10 Pack 3mm x 6cm | In distribution |
| OPTI1265BLK | 12mm x 65cm (Implant Size) | In distribution |
| PRES1030HRG10 | Helical 10 Regular 10mm x 30cm | In distribution |
| PRES0306HPK10 | Helical 10 Pack 3mm x 6cm | In distribution |
| OPTI0865BLK | 8mm x 65cm (Implant Size) | In distribution |
| OPTI0515CSFMX | Complex OptiMAX Soft – 5mm x 15cm | In distribution |
| OPTI0103BLK | 1mm x 3cm (Secondary Diameter x Length) | In distribution |
| PRES0517CRG10 | Complex 10 Regular 5mm x 17cm | In distribution |
| PRES0206HXP10 | Helical 10 Xtra Pack 2mm x 6cm | In distribution |
| PRES0413CPK10 | Complex 10 Pack 4mm x 13cm | In distribution |
| PRES0153HXP10 | Helical 10 Xtra Pack 1.5mm x 3cm | In distribution |
| OPTI0306CST10 | Complex Standard – 3mm x 6cm | In distribution |
| OPTI0258CSS10 | Complex Supersoft – 2.5mm x 8cm | In distribution |
| OPTI0965BLK | 9mm x 65cm (Implant Size) | In distribution |
| PRES0509CPK10 | Complex 10 Pack 5mm x 9cm | In distribution |
| OPTI1850CSFMX | Complex OptiMAX Soft – 18mm x 50cm | In distribution |
| PRES0154HXP10 | Helical 10 Xtra Pack 1.5mm x 4cm | In distribution |
| OPTI0410CSFMX | Complex OptiMAX Soft – 4mm x 10cm | In distribution |
| PRES0308CXP10 | Complex 10 Xtra Pack 3mm x 8cm | In distribution |
| OPTI0305HSSMX | Helical OptiMAX Supersoft – 3mm x 5cm | In distribution |
| PRES0151HXP10 | Helical 10 Xtra Pack 1.5mm x 1cm | In distribution |
| OPTI4510CSF10 | Complex Soft – 4.5mm x 10cm | In distribution |
| PRES0730HRG10 | Helical 10 Regular 7mm x 30cm | In distribution |
| OPTI1040HSFMX | Helical OptiMAX Soft – 10mm x 40cm | In distribution |
| PRES0310HXP10 | Helical 10 Xtra Pack 3mm x 10cm | In distribution |
| PRES0620CPK10 | Complex 10 Pack 6mm x 20cm | In distribution |
| PRES0830HRG10 | Helical 10 Regular 8mm x 30cm | In distribution |
| PRES0820HRG10 | Helical 10 Regular 8mm x 20cm | In distribution |
| OPTI0410HSFMX | Helical OptiMAX Soft – 4mm x 10cm | In distribution |
| PRES0611CPK10 | Complex 10 Pack 6mm x 11cm | In distribution |
| OPTI0358CSSMX | Complex OptiMAX Supersoft – 3.5mm x 8cm | In distribution |
| OPTI0930HSFMX | Helical OptiMAX Soft – 9mm x 30cm | In distribution |
| PRES0406HXP10 | Helical 10 Xtra Pack 4mm x 6cm | In distribution |
| PRES0408HXP10 | Helical 10 Xtra Pack 4mm x 8cm | In distribution |
| OPTI4545CSFMX | Complex OptiMAX Soft – 4.5mm x 4.5cm | In distribution |
| PRES0256HXP10 | Helical 10 Xtra Pack 2.5mm x 6cm | In distribution |
| OPTI0515HSFMX | Helical OptiMAX Soft – 5mm x 15cm | In distribution |
| PRES0620COM18 | Complex-18 6mm x 20cm | In distribution |
| PRES0306HXP10 | Helical 10 Xtra Pack 3mm x 4cm | In distribution |
| OPTI0204HSSMX | Helical OptiMAX Supersoft – 2mm x 4cm | In distribution |
| PRES0508HXP10 | Helical 10 Xtra Pack 5mm x 8cm | In distribution |
| PRES0102HXP10 | Helical 10 Xtra Pack 1mm x 2cm | In distribution |
| PRES0724CRG10 | Complex 10 Regular 7mm x 24cm | In distribution |
| PRES0720HRG10 | Helical 10 Regular 7mm x 20cm | In distribution |
| OPTI0420HSSMX | Helical OptiMAX Soft – 4mm x 20cm | In distribution |
| OPTI0435BLK | 4mm x 35cm (Implant Size) | In distribution |
| OPTI0620HSFMX | Helical OptiMAX Soft – 6mm x 20cm | In distribution |
| OPTI1515HSSMX | Helical OptiMAX Supersoft – 1.5mm x 1.5cm | In distribution |
| OPTI0735BLK | 7mm x 35cm (Secondary Diameter x Length) | In distribution |
| PRES0101CXP10 | Complex 10 Xtra Pack 1mm x 1cm | In distribution |
| OPTI0520CSF10 | Complex Soft – 5mm x 20cm | In distribution |
| OPTI0103BLK | 1mm x 3cm (Implant Size) | In distribution |
| PRES0406CXP10 | Complex 10 Xtra Pack 4mm x 6cm | In distribution |
| PRES0102CXP10 | Complex 10 Xtra Pack 1mm x 2cm | In distribution |
| OPTI0510CSFMX | Complex OptiMAX Soft – 5mm x 10cm | In distribution |
| PRES0104HXP10 | Helical 10 Xtra Pack 1mm x 4cm | In distribution |
| PRES0408HPK10 | Helical 10 Pack 4mm x 8cm | In distribution |
| OPTI0153BLK | 1.5mm x 3cm (Secondary Diameter x Length) | In distribution |
| PRES0256CXP10 | Complex 10 Xtra Pack 2.5mm x 6cm | In distribution |
| OPTI0208HSSMX | Helical OptiMAX Supersoft – 2mm x 8cm | In distribution |
| PRES0408CXP10 | Complex 10 Xtra Pack 4mm x 8cm | In distribution |
| OPTI0206BLKT | 2mm x 6cm (Implant Size) | In distribution |
| PRES0615HRG10 | Helical 10 Regular 6mm x 15cm | In distribution |
| OPTI0202HSSMX | Helical OptiMAX Supersoft – 2mm x 2cm | In distribution |
| PRES0308HPK10 | Helical 10 Pack 3mm x 8cm | In distribution |
| OPTI0310CSSMX | Complex OptiMAX Supersoft – 3mm x 10cm | In distribution |
| OPTI0715CSFMX | Complex OptiMAX Soft – 7mm x 15cm | In distribution |
| PRES0611CRG10 | Complex 10 Regular 6mm x 11cm | In distribution |
| PRES0508HPK10 | Helical 10 Pack 5mm x 8cm | In distribution |
| PRES1034COM18 | Complex-18 10mm x 34cm | In distribution |
| OPTI0255HSSMX | Helical OptiMAX Supersoft – 2.5mm x 5cm | In distribution |
| OPTI0258CSS10 | Complex Supersoft – 2.5mm x 8cm | In distribution |
| OPTI0635BLK | 6mm x 35cm (Implant Size) | In distribution |
| OPTI0510COM18 | Complex 18 – 5mm x 10cm | In distribution |
| OPTI2525HSSMX | Helical OptiMAX Supersoft – 2.5mm x 2.5cm | In distribution |
| OPTI0530BLK | 5mm x 30cm (Implant Size) | In distribution |
| OPTI0412CSS10 | Complex Supersoft – 4mm x 12cm | In distribution |
| PRES0208HXP10 | Helical 10 Xtra Pack 2mm x 8cm | In distribution |
| OPTI1140CSFMX | Complex OptiMAX Soft – 11mm x 40cm | In distribution |
| PRES0204CXP10 | Complex 10 Xtra Pack 2mm x 4cm | In distribution |
| OPTI2050CSFMX | Complex OptiMAX Soft – 20mm x 50cm | In distribution |
| OPTI0158BLK | 1.5mm x 8cm (Secondary Diameter x Length) | In distribution |
| PRES0152CXP10 | Complex 10 Xtra Pack 1.5mm x 2cm | In distribution |
| OPTI0103CSSMX | Complex Supersoft 18 – 1mm x 3cm | In distribution |
| OPTI0720CSFMX | Complex OptiMAX Soft – 7mm x 20cm | In distribution |
| PRES0827CRG10 | Complex 10 Regular 8mm x 27cm | In distribution |
| OPTI0404CSFMX | Complex OptiMAX Soft – 4mm x 4cm | In distribution |
| PRES0253CXP10 | Complex 10 Xtra Pack 2.5mm x 3cm | In distribution |
| PRES0154CXP10 | Complex 10 Xtra Pack 1.5mm x 4cm | In distribution |
| OPTI0750BLK | 7mm x 50cm (Secondary Diameter x Length) | In distribution |
| OPTI1030CSFMX | Complex OptiMAX Soft – 10mm x 30cm | In distribution |
| PRES0152HXP10 | Helical 10 Xtra Pack 1.5mm x 2cm | In distribution |
| OPTI0930CSFMX | Complex OptiMAX Soft – 9mm x 30cm | In distribution |
| OPTI4510CSF10 | Complex Soft – 4.5mm x 10cm | In distribution |
| OPTI0204CSSMX | Complex OptiMAX Supersoft – 2mm x 4cm | In distribution |
| OPTI0750BLK | 7mm x 50cm (Implant Size) | In distribution |
| PRES0713CPK10 | Complex 10 Pack 7mm x 13cm | In distribution |
| PRES0308CPK10 | Complex 10 Pack 3mm x 8cm | In distribution |
| PRES1447COM18 | Complex-18 14mm x 47cm | In distribution |
| PRES0510HXP10 | Helical 10 Xtra Pack 5mm x 10cm | In distribution |
| PRES0204HXP10 | Helical 10 Xtra Pack 2mm x 4cm | In distribution |
| PRES0406HPK10 | Helical 10 Pack 4mm x 6cm | In distribution |
| PRES0308HXP10 | Helical 10 Xtra Pack 3mm x 8cm | In distribution |
| OPTI0204BLK | 2mm x 4cm (Secondary Diameter x Length) | In distribution |
| OPTI0413CST10 | Complex Standard – 4mm x 13cm | In distribution |
| PRES0827CPK10 | Complex 10 Pack 8mm x 27cm | In distribution |
| PRES1655COM18 | Complex-18 16mm x 55cm | In distribution |
| OPTI0307CSSMX | Complex OptiMAX Supersoft – 3mm x 7cm | In distribution |
| OPTI0413CSFMX | Complex OptiMAX Soft – 4mm x 13cm | In distribution |
| OPTI0407CST10 | Complex Standard – 4mm x 7cm | In distribution |
| OPTI4540BLK | 4.5mm x 40cm (Implant Size) | In distribution |
| OPTI0308CST10 | Complex Standard – 3mm x 8cm | In distribution |
| OPTI0212BLK | Secondary Diameter x Length 2mm x 10cm | In distribution |
| OPTI0204BLK | 2mm x 4cm (Implant Size) | In distribution |
| OPTI0106BLK | 1mm x 6cm (Implant Size) | In distribution |
| OPTI0101HSSMX | Helical OptiMAX Supersoft – 1mm x 1cm | In distribution |
| OPTI0507CSFMX | Complex OptiMAX Soft – 5mm x 7cm | In distribution |
| PRES2465COM18 | Complex-18 24mm x 65cm | In distribution |
| PRES0724COM18 | Complex-18 7mm x 24cm | In distribution |
| PRES0103CXP10 | Complex 10 Xtra Pack 1mm x 3cm | In distribution |
| PRES1137COM18 | Complex-18 11mm x 37cm | In distribution |
| PRES0254HXP10 | Helical 10 Xtra Pack 2.5mm x 4cm | In distribution |
| PRES0253HXP10 | Helical 10 Xtra Pack 2.5mm x 3cm | In distribution |
| OPTI0615HSFMX | Helical OptiMAX Supersoft – 6mm x 15cm | In distribution |
| PRES0202HXP10 | Helical 10 Xtra Pack 2mm x 2cm | In distribution |
| PRES0306CXP10 | Complex 10 Xtra Pack 3mm x 6cm | In distribution |
| OPTI0308CST10 | Complex Standard – 3mm x 8cm | In distribution |
| OPTI1550CSFMX | Complex OptiMAX Soft – 15mm x 50cm | In distribution |
| OPTI0153BLKT | 1.5mm x 3cm (Implant Size) | In distribution |
| OPTI0407CST10 | Complex Standard – 4mm x 7cm | In distribution |
| PRES0620CRG10 | Complex 10 Regular 6mm x 20cm | In distribution |
| OPTI0830HSFMX | Helical OptiMAX Soft – 8mm x 30cm | In distribution |
| OPTI0615CSF10 | Complex Soft – 6mm x 15cm | In distribution |
| PRES0304HPK10 | Helical 10 Pack 3mm x 4cm | In distribution |
| OPTI0303CSSMX | Complex OptiMAX Supersoft – 3mm x 3cm | In distribution |
| OPTI0355CSSMX | Complex OptiMAX Supersoft – 3.5mm x 5cm | In distribution |
| PRES0310HPK10 | Helical 10 Pack 3mm x 10cm | In distribution |
| OPTI0212BLKT | 2mm x 12cm (Implant Size) | In distribution |
| OPTI0320BLK | 3mm x 20cm (Secondary Diameter x Length) | In distribution |
| OPTI0310HSSMX | Helical OptiMAX Supersoft – 3mm x 10cm | In distribution |
| PRES0608HPK10 | Helical 10 Pack 6mm x 8cm | In distribution |
| OPTI4510CSFMX | Complex OptiMAX Soft – 4.5mm x 10cm | In distribution |
| OPTI1650CSFMX | Complex OptiMAX Soft – 16mm x 50cm | In distribution |
| OPTI0102HSSMX | Helical OptiMAX Supersoft – 1mm x 2cm | In distribution |
| OPTI0509CST10 | Complex Standard – 5mm x 9cm | In distribution |
| OPTI0203CSSMX | Complex OptiMAX Supersoft – 2mm x 3cm | In distribution |
| PRES0506HXP10 | Helical 10 Xtra Pack 5mm x 6cm | In distribution |
| OPTI0206BLK | 2mm x 6cm (Secondary Diameter x Length) | In distribution |
| PRES0713CRG10 | Complex 10 Regular 7mm x 13cm | In distribution |
| PRES0103HXP10 | Helical 10 Xtra Pack 1mm x 3cm | In distribution |
| OPTI0615CSFMX | Complex OptiMAX Soft – 6mm x 15cm | In distribution |
| PRES0517CPK10 | Complex 10 Pack 5mm x 17cm | In distribution |
| PRES0506HPK10 | Helical 10 Pack 5mm x 6cm | In distribution |
| OPTI0520CSF10 | Complex Soft – 5mm x 20cm | In distribution |
| PRES0610HPK10 | Helical 10 Pack 6mm x 10cm | In distribution |
| PRES0620HRG10 | Helical 10 Regular 6mm x 20cm | In distribution |
| OPTI0830CSFMX | Complex OptiMAX Soft – 8mm x 30cm | In distribution |
| PRES0358CXP10 | Complex 10 Xtra Pack 3.5mm x 8cm | In distribution |
| OPTI1445CSFMX | Complex OptiMAX Soft- 14mm x 45cm | In distribution |
| OPTI0206CSSMX | Complex OptiMAX Supersoft – 2mm x 6cm | In distribution |
| PRES0930COM18 | Complex-18 9mm x 30cm | In distribution |
| OPTI0106BLKT | 1mm x 6cm (Implant Size) | In distribution |
| OPTI0156BLKT | 1.5mm x 6cm (Implant Size) | In distribution |
| OPTI0417CSF10 | Complex Soft – 4mm x 17cm | In distribution |
| PRES0508CXP10 | Complex 10 Xtra Pack 5mm x 8cm | In distribution |
| PRES0208CPK10 | Complex 10 Pack 2mm x 8cm | In distribution |
| OPTI0540BLK | 5mm x 40cm (Implant Size) | In distribution |
| OPTI0845BLK | 8mm x 45cm (Secondary Diameter x Length) | In distribution |
| PRES0606HPK10 | Helical 10 Pack 6mm x 6cm | In distribution |
| PRES0510HPK10 | Helical 10 Pack 5mm x 10cm | In distribution |
| OPTI0356CSF10 | Complex Soft – 3.5mm x 6cm | In distribution |
| OPTI0152CSSMX | Complex OptiMAX Supersoft – 1.5mm x 2cm | In distribution |
| PRES0930CRG10 | Complex 10 Regular 9mm x 30cm | In distribution |
| OPTI0965BLK | 9mm x 65cm (Secondary Diameter x Length) | In distribution |
| PRES0254CXP10 | Complex 10 Xtra Pack 2.5mm x 4cm | In distribution |
| OPTI0103BLKT | 1mm x 3cm (Implant Size) | In distribution |
| PRES1034CRG10 | Complex 10 Regular 10mm x 34cm | In distribution |
| PRES1027CRG10 | Complex 10 Regular 10mm x 27cm | In distribution |
| OPTI0206HSSMX | Helical OptiMAX Supersoft – 2mm x 6cm | In distribution |
| PRES0310CPK10 | Complex 10 Pack 3mm x 10cm | In distribution |
| OPTI3520BLK | 3.5mm x 20cm (Secondary Diameter x Length) | In distribution |
| PRES0513CXP10 | Complex 10 Xtra Pack 5mm x 13cm | In distribution |
| PRES1550COM18 | Complex-18 15mm x 50cm | In distribution |
| OPTI0820CSFMX | Complex OptiMAX Soft – 8mm x 20cm | In distribution |
| OPTI1245CSFMX | Complex OptiMAX Soft – 12mm x 45cm | In distribution |
| OPTI0412HSFMX | Helical OptiMAX Soft – 4mm x 12cm | In distribution |
| PRES0206CXP10 | Complex 10 Xtra Pack 2mm x 6cm | In distribution |
| PRES0410HPK10 | Helical 10 Pack 4mm x 10cm | In distribution |
| OPTI0540BLK | 5mm x 40cm (Secondary Diameter x Length) | In distribution |
| OPTI0865BLK | 8mm x 65cm (Secondary Diameter x Length) | In distribution |
| OPTI0520HSFMX | Helical OptiMAX Soft – 5mm x 20cm | In distribution |
| OPTI1065BLK | 10mm x 65cm (Implant Size) | In distribution |
| OPTI0620CSFMX | Complex OptiMAX Soft – 6mm x 20cm | In distribution |
| OPTI0410CSF10 | Complex Soft – 4mm x 10cm | In distribution |
| PRES0410CXP10 | Complex 10 Xtra Pack 4mm x 10cm | In distribution |
| OPTI0103HSSMX | Helical OptiMAX Supersoft – 1mm x 3cm | In distribution |
| OPTI3535CSSMX | Complex OptiMAX Supersoft – 3.5mm x 3.5cm | In distribution |
| PRES0203CXP10 | Complex 10 Xtra Pack 2mm x 3cm | In distribution |
| OPTI0153CSSMX | Complex OptiMAX Supersoft – 1.5mm x 3cm | In distribution |
| PRES0203CPK10 | Complex 10 Pack 2mm x 3cm | In distribution |
| OPTI1040CSFMX | Complex OptiMAX Soft – 10mm x 40cm | In distribution |
| OPTI0310BLK | 3mm x 10cm (Secondary Diameter x Length) | In distribution |
| OPTI0615CSF10 | Complex Soft – 6mm x 15cm | In distribution |
| OPTI0517BLK | 5mm x 17cm (Implant Size) | In distribution |
| PRES0510CXP10 | Complex 10 Xtra Pack 5mm x 10cm | In distribution |
| OPTI3520BLK | 3.5mm x 20cm (Implant Size) | In distribution |
| OPTI0101CSSMX | Complex OptiMAX Supersoft 18 – 1mm x 1cm | In distribution |
| PRES1860COM18 | Complex-18 18mm x 60cm | In distribution |
| PRES0304CXP10 | Complex 10 Xtra Pack 3mm x 4cm | In distribution |
| OPTI0517BLK | 5mm x 17cm (Secondary Diameter x Length) | In distribution |
| PRES0203HXP10 | Helical 10 Xtra Pack 2mm x 3cm | In distribution |
| PRES0206CPK10 | Complex 10 Pack 2mm x 6cm | In distribution |
Showing 250 of 255 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prestige Coil System | Balt USA, LLC | 339 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 279 |
| AxiumTM | Micro Therapeutics, Inc. | 255 |
| Avenir | Shanghai Wallaby Medical Technologies Co., Inc. | 184 |
| MReye | Cook Incorporated | 167 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 162 |
| Nester | Cook Incorporated | 160 |
| Axium | Micro Therapeutics, Inc. | 146 |
| ConcertoTM | Micro Therapeutics, Inc. | 133 |
| Tornado | Cook Incorporated | 111 |
| V-Trak | MicroVention, Inc. | 105 |
| HydroFrame 10 Advanced | MicroVention, Inc. | 104 |
Showing 12 of 158. All products under Device, Vascular, For Promoting Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251383 | 2025-05-30 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Balt USA, LLC | 510(k) number | 2025-05-08 | Class II | Vendor change control | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. | 2889 devices |
| Balt USA, LLC | 510(k) number | 2024-01-03 | Class II | Material/Component Contamination | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the d | 31785 coils |
| Balt USA, LLC | 510(k) number | 2022-09-07 | Class II | Error in labeling | Product pouch label does not match up with carton label | 41 impacted devices |
| Balt USA, LLC | 510(k) number | 2022-07-26 | Class II | Under Investigation by firm | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. | 4 devices |
| Balt USA, LLC | 510(k) number | 2022-01-04 | Class II | Process control | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting th | 51 devices |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-05-08 | Class II | Vendor change control | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. | 1754 devices |
| 2024-01-03 | Class II | Material/Component Contamination | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the d | 2802 coils |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P780011 | 1988-01-29 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.