Optima Coil System
307 catalogue numbers from OPTI0308CSF10, listed by Balt USA, LLC, United States, under Device, Neurovascular Embolization. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
307catalogue numbers in this listing
5510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Balt USA, LLC, United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K172390 |
| Record published | 2018-09-01 |
| Record revised | 2021-02-05 (version 2) |
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 |
|---|---|---|
| OPTI0308CSF10 | Complex-10 Soft 3mm x 8cm | In distribution |
| OPTI0510HSS10 | Helical-10 SuperSoft 5mm x 10cm | In distribution |
| OPTI0258BLK | 2.5mm x 8cm (Implant Size) | In distribution |
| OPTI0724COM18 | Complex-18 7mm x 24cm | In distribution |
| OPTIFILL1014 | 2mm x 10cm (Secondary Diameter x Length) | In distribution |
| OPTIPAX3014 | 2mm x 30cm (Secondary Diameter x Length) | In distribution |
| OPTI2512BLK | 2.5mm x 12cm (Implant Size) | In distribution |
| OPTI0513CSS10 | Complex-10 SuperSoft 5mm x 13cm | In distribution |
| OPTI0506HSF10 | Helical Soft 5mm x 6cm | In distribution |
| OPTI0713CST10 | Complex-10 Standard 7mm x 13cm | In distribution |
| OPTI0827CSF10 | Complex-10 Soft 8mm x 27cm | In distribution |
| OPTI0206CSS10 | Complex-10 SuperSoft 2mm x 6cm | In distribution |
| OPTI0104CSS10 | Complex-10 SuperSoft 1mm x 4cm | In distribution |
| OPTI0208HSS10 | Helical-10 SuperSoft 2mm x 8cm | In distribution |
| OPTI0308HSS10 | Helical-10 SuperSoft 3mm x 8cm | In distribution |
| OPTI0101CSS10 | Complex-10 Super Soft 1mm x 1cm | In distribution |
| OPTI1027CST10 | Complex-10 Standard 10mm x 27cm | In distribution |
| OPTI0820HST10 | Helical-10 Standard 8mm x 20cm | In distribution |
| OPTI0306CSF10 | Complex-10 Soft 3mm x 6cm | In distribution |
| OPTI0256CSS10 | Complex-10 SuperSoft 2.5mm x 6cm | In distribution |
| OPTI0206HSS10 | Helical-10 SuperSoft 2mm x 6cm | In distribution |
| OPTI0304HSF10 | Helical Soft 3mm x 4cm | In distribution |
| OPTI0410HSS10 | Helical-10 SuperSoft 4mm x 10cm | In distribution |
| OPTI0506HSS10 | Helical-10 SuperSoft 5mm x 6cm | In distribution |
| OPTI0103HSS10 | Helical-10 SuperSoft 1mm x 3cm | In distribution |
| OPTI0356CSS10 | Complex-10 SuperSoft 3.5mm x 6cm | In distribution |
| OPTI0204HSS10 | Helical-10 SuperSoft 2mm x 4cm | In distribution |
| OPTI2520BLK | 2.5mm x 20cm (Implant Size) | In distribution |
| OPTI0204HSS10 | Helical-10 SuperSoft 2mm x 4cm | In distribution |
| OPTI0930COM18 | Complex-18 9mm x 30cm | In distribution |
| OPTI0256HSS10 | Helical-10 SuperSoft 2.5mm x 6cm | In distribution |
| OPTI0510COM18 | Complex 18 – 5mm x 10cm | In distribution |
| OPTI1655COM18 | Complex-18 16mm x 55cm | In distribution |
| OPTI1860COM18 | Complex-18 18mm x 60cm | In distribution |
| OPTI0308HSS10 | Helical-10 SuperSoft 3mm x 8cm | In distribution |
| OPTI2265COM18 | Complex-18 22mm x 65cm | In distribution |
| OPTI0615HST10 | Helical-10 Standard 6mm x 15cm | In distribution |
| OPTIFILL4514 | 2mm x 45cm (Secondary Diameter x Length) | In distribution |
| OPTI0310CSF10 | Complex-10 Soft 3mm x 10cm | In distribution |
| OPTI0724CSF10 | Complex-10 Soft 7mm x 24cm | In distribution |
| OPTI0724CST10 | Complex-10 Standard 7mm x 24cm | In distribution |
| OPTI0820HST10 | Helical-10 Standard 8mm x 20cm | In distribution |
| OPTI0420HSF10 | Helical Soft – 4mm x 20cm | In distribution |
| OPTI0101HSS10 | Helical-10 SuperSoft 1mm x 1cm | In distribution |
| OPTI1860COM18 | Complex-18 18mm x 60cm | In distribution |
| OPTI0620HSF10 | Helical Soft – 6mm x 20cm | In distribution |
| OPTI0410HSF10 | Helical Soft 4mm x 10cm | In distribution |
| OPTI0101HSS10 | Helical-10 SuperSoft 1mm x 1cm | In distribution |
| OPTI0254CSS10 | Complex-10 SuperSoft 2.5mm x 4cm | In distribution |
| OPTI0206BLK | 2mm x 6cm (Implant Size) | In distribution |
| OPTIPAX4514 | 2mm x 45cm (Secondary Diameter x Length) | In distribution |
| OPTIPAX3014 | 2mm x 30cm (Secondary Diameter x Length) | In distribution |
| OPTI0620COM18 | Complex-18 6mm x 20cm | In distribution |
| OPTI0308CSS10 | Complex-10 SuperSoft 3mm x 8cm | In distribution |
| OPTI0256HSS10 | Helical-10 SuperSoft 2.5mm x 6cm | In distribution |
| OPTI0253CSS10 | Complex-10 SuperSoft 2.5mm x 3cm | In distribution |
| OPTI4520BLK | 4.5mm x 20cm (Implant Size) | In distribution |
| OPTI0156BLK | 1.5mm x 6cm (Implant Size) | In distribution |
| OPTI0407CSF10 | Complex-10 Soft 4mm x 7cm | In distribution |
| OPTI0253HSS10 | Helical-10 SuperSoft 2.5mm x 3cm | In distribution |
| OPTIPAX0514 | 2mm x 5cm (Secondary Diameter x Length) | In distribution |
| OPTI0310CSF10 | Complex-10 Soft 3mm x 10cm | In distribution |
| OPTI0406HSS10 | Helical-10 SuperSoft 4mm x 6cm | In distribution |
| OPTIFILL6514 | 2mm x 65cm (Secondary Diameter x Length) | In distribution |
| OPTI0102CSS10 | Complex-10 SuperSoft 1mm x 2cm | In distribution |
| OPTI2065COM18 | Complex-18 20mm x 65cm | In distribution |
| OPTI0923CST10 | Complex-10 Standard 9mm x 23cm | In distribution |
| OPTI0103CSS10 | Complex-10 SuperSoft 1mm x 3cm | In distribution |
| OPTI0315HSF10 | Helical Soft – 3mm x 15cm | In distribution |
| OPTI0510HSF10 | Helical Soft 5mm x 10cm | In distribution |
| OPTI0830HST10 | Helical-10 Standard 8mm x 30cm | In distribution |
| OPTI0154CSS10 | Complex-10 SuperSoft 1.5mm x 4cm | In distribution |
| OPTI1027CST10 | Complex-10 Standard 10mm x 27cm | In distribution |
| OPTI0356CSF10 | Complex Soft – 3.5mm x 6cm | In distribution |
| OPTI0304CSS10 | Complex-10 SuperSoft 3mm x 4cm | In distribution |
| OPTI0506HSF10 | Helical Soft 5mm x 6cm | In distribution |
| OPTI0407CSF10 | Complex-10 Soft 4mm x 7cm | In distribution |
| OPTI0306HSF10 | Helical Soft 3mm x 6cm | In distribution |
| OPTI0720HST10 | Helical-10 Standard 7mm x 20cm | In distribution |
| OPTI0513CSS10 | Complex-10 SuperSoft 5mm x 13cm | In distribution |
| OPTI0206HSS10 | Helical-10 SuperSoft 2mm x 6cm | In distribution |
| OPTI0509CSF10 | Complex-10 Soft 5mm x 9cm | In distribution |
| OPTI0254HSS10 | Helical-10 SuperSoft 2.5mm x 4cm | In distribution |
| OPTI0427BLK | 4mm x 27cm (Implant Size) | In distribution |
| OPTI0330BLK | 3mm x 30cm (Implant Size) | In distribution |
| OPTIPAX6514 | 2mm x 65cm (Secondary Diameter x Length) | In distribution |
| OPTI1343COM18 | Complex-18 13mm x 43cm | In distribution |
| OPTI0156BLK | 1.5mm x 6cm (Secondary Diameter x Length) | In distribution |
| OPTI0210CSS10 | Complex Supersoft – 2mm x 10cm | In distribution |
| OPTI1550COM18 | Complex-18 15mm x 50cm | In distribution |
| OPTI1030HST10 | Helical-10 Standard 10mm x 30cm | In distribution |
| OPTI0203CSS10 | Complex-10 SuperSoft 2mm x 3cm | In distribution |
| OPTIFILL6514 | 2mm x 65cm (Secondary Diameter x Length) | In distribution |
| OPTI0255CSF10 | Complex-10 Soft 2.5mm x 5cm | In distribution |
| OPTI0258BLK | 2.5mm x 8cm (Secondary Diameter x Length) | In distribution |
| OPTI0153HSS10 | Helical-10 SuperSoft 1.5mm x 3cm | In distribution |
| OPTI0508HSF10 | Helical Soft 5mm x 8cm | In distribution |
| OPTI0154CSS10 | Complex-10 SuperSoft 1.5mm x 4cm | In distribution |
| OPTI0206CSF10 | Complex-10 Soft 2mm x 6cm | In distribution |
| OPTI0208CSS10 | Complex-10 SuperSoft 2mm x 8cm | In distribution |
| OPTI2265COM18 | Complex-18 22mm x 65cm | In distribution |
| OPTI0151HSS10 | Helical-10 SuperSoft 1.5mm x 1cm | In distribution |
| OPTI0206CSS10 | Complex-10 SuperSoft 2mm x 6cm | In distribution |
| OPTI0606HSF10 | Helical Soft 6mm x 6cm | In distribution |
| OPTI0408CSS10 | Complex-10 SuperSoft 4mm x 8cm | In distribution |
| OPTI0720HST10 | Helical-10 Standard 7mm x 20cm | In distribution |
| OPTI0830HST10 | Helical-10 Standard 8mm x 30cm | In distribution |
| OPTI0320BLK | 3mm x 20cm (Implant Size) | In distribution |
| OPTI0713CSF10 | Complex-10 Soft 7mm x 13cm | In distribution |
| OPTI0253HSS10 | Helical-10 SuperSoft 2.5mm x 3cm | In distribution |
| OPTI0254HSS10 | Helical-10 SuperSoft 2.5mm x 4cm | In distribution |
| OPTI0608HSF10 | Helical Soft 6mm x 8cm | In distribution |
| OPTI0152CSS10 | Complex-10 SuperSoft 1.5mm x 2cm | In distribution |
| OPTI0153CSS10 | Complex-10 SuperSoft 1.5mm x 3cm | In distribution |
| OPTI0203CSS10 | Complex-10 SuperSoft 2mm x 3cm | In distribution |
| OPTI0153CSS10 | Complex-10 SuperSoft 1.5mm x 3cm | In distribution |
| OPTI0208CSS10 | Complex-10 SuperSoft 2mm x 8cm | In distribution |
| OPTI0304HSS10 | Helical-10 SuperSoft 3mm x 4cm | In distribution |
| OPTI0408HSS10 | Helical-10 SuperSoft 4mm x 8cm | In distribution |
| OPTI1030HST10 | Helical-10 Standard 10mm x 30cm | In distribution |
| OPTI0253CSS10 | Complex-10 SuperSoft 2.5mm x 3cm | In distribution |
| OPTI0816CSF10 | Complex-10 Soft 8mm x 16cm | In distribution |
| OPTI1343COM18 | Complex-18 13mm x 43cm | In distribution |
| OPTI0308CSS10 | Complex-10 SuperSoft 3mm x 8cm | In distribution |
| OPTI0506HSS10 | Helical-10 SuperSoft 5mm x 6cm | In distribution |
| OPTI0724COM18 | Complex-18 7mm x 24cm | In distribution |
| OPTI0713CST10 | Complex-10 Standard 7mm x 13cm | In distribution |
| OPTI0408HSF10 | Helical Soft 4mm x 8cm | In distribution |
| OPTI0930HST10 | Helical-10 Standard 9mm x 30cm | In distribution |
| OPTI1465BLK | 14mm x 65cm (Implant Size) | In distribution |
| OPTI0220BLK | 2mm x 20cm (Implant Size) | In distribution |
| OPTI0517CST10 | Complex-10 Standard 5mm x 17cm | In distribution |
| OPTIFILL4514 | 2mm x 45cm (Secondary Diameter x Length) | In distribution |
| OPTI0635BLK | 6mm x 35cm (Secondary Diameter x Length) | In distribution |
| OPTI0308HSF10 | Helical Soft 3mm x 8cm | In distribution |
| OPTI0816CST10 | Complex-10 Standard 8mm x 16cm | In distribution |
| OPTI0408CSS10 | Complex-10 SuperSoft 4mm x 8cm | In distribution |
| OPTI0203CSF10 | Complex-10 Soft 2mm x 3cm | In distribution |
| OPTI0930HST10 | Helical-10 Standard 9mm x 30cm | In distribution |
| OPTI0509CSF10 | Complex-10 Soft 5mm x 9cm | In distribution |
| OPTI0610HSF10 | Helical Soft – 6mm x 20cm | In distribution |
| OPTI0410CSS10 | Complex-10 SuperSoft 4mm x 10cm | In distribution |
| OPTI0104HSS10 | Helical-10 SuperSoft 1mm x 4cm | In distribution |
| OPTI0827CST10 | Complex-10 Standard 8mm x 27cm | In distribution |
| OPTI0510HSS10 | Helical-10 SuperSoft 5mm x 10cm | In distribution |
| OPTIPAX1512 | 2mm x 15cm (Secondary Diameter x Length) | In distribution |
| OPTI0315BLK | 3mm x 15cm (Implant Size) | In distribution |
| OPTI0304HSS10 | Helical-10 SuperSoft 3mm x 4cm | In distribution |
| OPTI0255CSF10 | Complex-10 Soft 2.5mm x 5cm | In distribution |
| OPTI1137COM18 | Complex-18 11mm x 37cm | In distribution |
| OPTI0410CSS10 | Complex-10 SuperSoft 4mm x 10cm | In distribution |
| OPTI0827CST10 | Complex-10 Standard 8mm x 27cm | In distribution |
| OPTI0406CSS10 | Complex-10 SuperSoft 4mm x 6cm | In distribution |
| OPTIFILL1012 | 2mm x 10cm (Secondary Diameter x Length) | In distribution |
| OPTIFILL0514 | 2mm x 5cm (Secondary Diameter x Length) | In distribution |
| OPTI0435BLK | 4mm x 35cm (Secondary Diameter x Length) | In distribution |
| OPTI0310HSS10 | Helical-10 SuperSoft 3mm x 10cm | In distribution |
| OPTI2065COM18 | Complex-18 20mm x 65cm | In distribution |
| OPTI0730HST10 | Helical-10 Standard 7mm x 30cm | In distribution |
| OPTI0306HSF10 | Helical Soft 3mm x 6cm | In distribution |
| OPTI2465COM18 | Complex-18 24mm x 65cm | In distribution |
| OPTI0520HSF10 | Helical Soft – 5mm x 20cm | In distribution |
| OPTI0152CSS10 | Complex-10 SuperSoft 1.5mm x 2cm | In distribution |
| OPTI0620COM18 | Complex-18 6mm x 20cm | In distribution |
| OPTI0206CSF10 | Complex-10 Soft 2mm x 6cm | In distribution |
| OPTIFILL0512 | 2mm x 5cm (Secondary Diameter x Length) | In distribution |
| OPTI0517CST10 | Complex Standard – 5mm x 17cm | In distribution |
| OPTI0408HSS10 | Helical-10 SuperSoft 4mm x 8cm | In distribution |
| OPTI1240COM18 | Complex-18 12mm x 40cm | In distribution |
| OPTI0620CST10 | Complex-10 Standard 6mm x 20cm | In distribution |
| OPTI0102HSS10 | Helical-10 SuperSoft 1mm x 2cm | In distribution |
| OPTI0152HSS10 | Helical-10 SuperSoft 1.5mm x 2cm | In distribution |
| OPTI0208HSS10 | Helical-10 SuperSoft 2mm x 8cm | In distribution |
| OPTI0310HSS10 | Helical-10 SuperSoft 3mm x 10cm | In distribution |
| OPTI0410HSS10 | Helical-10 SuperSoft 4mm x 10cm | In distribution |
| OPTI0310BLK | 3mm x 10cm (Implant Size) | In distribution |
| OPTI0310CSS10 | Complex-10 SuperSoft 3mm x 10cm | In distribution |
| OPTI3530BLK | 3.5mm x 30cm (Implant Size) | In distribution |
| OPTI0410HSF10 | Helical Soft 4mm x 10cm | In distribution |
| OPTI0306CSS10 | Complex-10 SuperSoft 3mm x 6cm | In distribution |
| OPTI0508HSF10 | Helical Soft 5mm x 8cm | In distribution |
| OPTI0720BLK | 7mm x 20cm (Secondary Diameter x Length) | In distribution |
| OPTI0420BLK | 4mm x 20cm (Secondary Diameter x Length) | In distribution |
| OPTI0608HSF10 | Helical Soft 6mm x 8cm | In distribution |
| OPTIFILL3014 | 2mm x 30cm (Secondary Diameter x Length) | In distribution |
| OPTI0208CSF10 | Complex-10 Soft 2mm x 8cm | In distribution |
| OPTI0508CSS10 | Complex-10 SuperSoft 5mm x 8cm | In distribution |
| OPTI0620HST10 | Helical-10 Standard 6mm x 20cm | In distribution |
| OPTI0304CSS10 | Complex-10 SuperSoft 3mm x 4cm | In distribution |
| OPTI0420HSF10 | Helical Soft – 4mm x 20cm | In distribution |
| OPTI0358CSS10 | Complex-10 SuperSoft 3.5mm x 8cm | In distribution |
| OPTIPAX1014 | 2mm x 10cm (Secondary Diameter x Length) | In distribution |
| OPTI0310HSF10 | Helical Soft 3mm x 10cm | In distribution |
| OPTI1034CST10 | Complex-10 Standard 10mm x 34cm | In distribution |
| OPTI0202HSS10 | Helical-10 SuperSoft 2mm x 2cm | In distribution |
| OPTI0208CSF10 | Complex-10 Soft 2mm x 8cm | In distribution |
| OPTI0204CSS10 | Complex-10 SuperSoft 2mm x 4cm | In distribution |
| OPTI1550COM18 | Complex-18 15mm x 50cm | In distribution |
| OPTI0606HSF10 | Helical Soft 6mm x 6cm | In distribution |
| OPTI3530BLK | 3.5mm x 30cm (Secondary Diameter x Length) | In distribution |
| OPTIFILL1514 | 2mm x 15cm (Secondary Diameter x Length) | In distribution |
| OPTI0930CST10 | Complex-10 Standard 9mm x 30cm | In distribution |
| OPTIPAX1514 | 2mm x 15cm (Secondary Diameter x Length) | In distribution |
| OPTI1034CST10 | Complex-10 Standard 10mm x 34cm | In distribution |
| OPTI0101CSS10 | Complex-10 Super Soft 1mm x 1cm | In distribution |
| OPTI0204CSF10 | Complex-10 Soft 2mm x 4cm | In distribution |
| OPTI0102CSS10 | Complex-10 SuperSoft 1mm x 2cm | In distribution |
| OPTI1265BLK | 12mm x 65cm (Secondary Diameter x Length) | In distribution |
| OPTI0152HSS10 | Helical-10 SuperSoft 1.5mm x 2cm | In distribution |
| OPTI0406HSF10 | Helical Soft 4mm x 6cm | In distribution |
| OPTI0408HSF10 | Helical Soft 4mm x 8cm | In distribution |
| OPTI0256CSS10 | Complex-10 SuperSoft 2.5mm x 6cm | In distribution |
| OPTI0510HSF10 | Helical Soft 5mm x 10cm | In distribution |
| OPTIPAX1012 | 2mm x 10cm (Secondary Diameter x Length) | In distribution |
| OPTI0923CST10 | Complex-10 Standard 9mm x 23cm | In distribution |
| OPTIPAX4514 | 2mm x 45cm (Secondary Diameter x Length) | In distribution |
| OPTI0611CSF10 | Complex-10 Soft 6mm x 11cm | In distribution |
| OPTI0308CSF10 | Complex-10 Soft 3mm x 8cm | In distribution |
| OPTI0406CSS10 | Complex-10 SuperSoft 4mm x 6cm | In distribution |
| OPTI0930CST10 | Complex-10 Standard 9mm x 30cm | In distribution |
| OPTI0310CSS10 | Complex-10 SuperSoft 3mm x 10cm | In distribution |
| OPTI0611CSF10 | Complex-10 Soft 6mm x 11cm | In distribution |
| OPTI0517CSF10 | Complex-10 Soft 5mm x 17cm | In distribution |
| OPTI1065BLK | 10mm x 65cm (Secondary Diameter x Length) | In distribution |
| OPTI1137COM18 | Complex-18 11mm x 37cm | In distribution |
| OPTI0203HSS10 | Helical-10 SuperSoft 2mm x 3cm | In distribution |
| OPTI1510BLK | 1.5mm x 10cm (Implant Size) | In distribution |
| OPTI1447COM18 | Complex-18 14mm x 47cm | In distribution |
| OPTI0154HSS10 | Helical-10 SuperSoft 1.5mm x 4cm | In distribution |
| OPTI1034COM18 | Complex-18 10mm x 34cm | In distribution |
| OPTI0310HSF10 | Helical Soft 3mm x 10cm | In distribution |
| OPTI0615HST10 | Helical-10 Standard 6mm x 15cm | In distribution |
| OPTI0827CSF10 | Complex-10 Soft 8mm x 27cm | In distribution |
| OPTI0406HSS10 | Helical-10 SuperSoft 4mm x 6cm | In distribution |
| OPTI0816CSF10 | Complex-10 Soft 8mm x 16cm | In distribution |
| OPTI0153BLK | 1.5mm x 3cm (Implant Size) | In distribution |
| OPTI0610HSF10 | Helical Soft 6mm x 10cm | In distribution |
| OPTI0930COM18 | Complex-18 9mm x 30cm | In distribution |
| OPTI0611CST10 | Complex-10 Standard 6mm x 11cm | In distribution |
| OPTI0254CSS10 | Complex-10 SuperSoft 2.5mm x 4cm | In distribution |
| OPTI0413CSF10 | Complex-10 Soft 4mm x 13cm | In distribution |
| OPTI2465COM18 | Complex-18 24mm x 65cm | In distribution |
| OPTI0158BLK | 1.5mm x 8cm (Implant Size) | In distribution |
| OPTI0104HSS10 | Helical-10 SuperSoft 1mm x 4cm | In distribution |
| OPTI0202CSS10 | Complex-10 SuperSoft 2mm x 2cm | In distribution |
| OPTI0510CSS10 | Complex-10 SuperSoft 5mm x 10cm | In distribution |
| OPTI0104CSS10 | Complex-10 SuperSoft 1mm x 4cm | In distribution |
| OPTI1240COM18 | Complex-18 12mm x 40cm | In distribution |
| OPTI0827COM18 | Complex-18 8mm x 27cm | In distribution |
| OPTI0730HST10 | Helical-10 Standard 7mm x 30cm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
| Trufill DCS Orbit | Cerenovus, Inc. | 74 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254221 | 2026-01-27 |
| K252700 | 2025-09-26 |
| K242582 | 2024-09-27 |
| K223386 | 2022-12-06 |
| K200030 | 2020-02-01 |
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 |
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.