Prestige Coil System
The Prestige Packing Coil consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery…
The Prestige Packing Coil consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Prestige Packing Coil delivery pusher is 185cm in length. It is designed for use with the Ultra Detachment Controller. The Ultra Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Prestige Packing Coil and Ultra Detachment Controller(s) are sold separately. The Prestige Packing Coil achieves detachment by an internal heater element, which is powered by the Ultra Detachment Controller.
6manufacturers in China registered for this device type
339catalogue 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) | K220699 |
| Record published | 2024-11-20 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at a controlled room temperature in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRES0713CPK10 | In distribution | |
| PRES1145CPKPLT | PRESTIGE PLUS COMPLEX PACK 11mm x 45cm | In distribution |
| PRES1137COM18 | In distribution | |
| PRES0308HPK10 | In distribution | |
| PRES1465CPKPLT | PRESTIGE PLUS COMPLEX PACK 14mm x 65cm | In distribution |
| PRES0724CRG10 | In distribution | |
| PRES0620CRG10 | In distribution | |
| PRES0410HPKPL | In distribution | |
| PRES0720HPKPL | In distribution | |
| PRES0923CRG10 | In distribution | |
| PRES0820CPKPL | In distribution | |
| PRES0410CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0315HXPPL | In distribution | |
| PRES0404CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1447COM18 | In distribution | |
| PRES0515CPKPL | In distribution | |
| PRES0202HXP10 | In distribution | |
| PRES0510CPKPL | In distribution | |
| PRES0307CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0102CXPPL | In distribution | |
| PRES0303CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES4510CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0204CXPPLT | PRESTIGE PLUS COMPLEX XTRA PACK 2mm x 4cm | In distribution |
| PRES0410CPKPLT | PRESTIGE PLUS COMPLEX PACK 4mm x 10cm | In distribution |
| PRES0153CXPPLT | PRESTIGE PLUS COMPLEX XTRA PACK 1.5mm x 3cm | In distribution |
| PRES0608HPK10 | In distribution | |
| PRES0308CRG10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0255CXPPL | In distribution | |
| PRES1045CPKPLT | PRESTIGE PLUS COMPLEX PACK 10mm x 45cm | In distribution |
| PRES0865HPKPL | PRESTIGE PLUS HELICAL PACK 8mm x 65cm | In distribution |
| PRESPACK30 | Secondary Diameter x Length: 2mm x 30cm | In distribution |
| PRESPACK30V02 | Secondary Diameter x Length: 2mm x 30cm | In distribution |
| PRES0204HXP10 | In distribution | |
| PRES0615HPKPL | In distribution | |
| PRES0356CXP10 | In distribution | |
| PRES1140CPKPL | In distribution | |
| PRES2525CXPPL | In distribution | |
| PRES0202CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRESPACK55 | Secondary Diameter x Length: 2mm x 55cm | In distribution |
| PRES0620HPK10 | In distribution | |
| PRES0408HXP10 | In distribution | |
| PRES0310CPK10 | In distribution | |
| PRES0206CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0830HPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1550CPKPLT | PRESTIGE PLUS COMPLEX PACK 15mm x 50cm | In distribution |
| PRES2265CPKPLT | PRESTIGE PLUS COMPLEX PACK 22mm x 65cm | In distribution |
| PRES0258CXP10 | PRESTIGE PLUS COMPLEX XTRA PACK 1mm x 3cm | In distribution |
| PRES0253HXP10 | In distribution | |
| PRES3512CXPPLT | PRESTIGE PLUS COMPLEX XTRA PACK 3.5mm x 12cm | In distribution |
| PRES0508HPK10 | In distribution | |
| PRES0306CRG10 | In distribution | |
| PRES0412HPKPL | In distribution | |
| PRES0930HPKPL | In distribution | |
| PRES0408CXP10 | In distribution | |
| PRES0310HPK10 | In distribution | |
| PRES0101CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0510CXP10 | In distribution | |
| PRES0410CXP10 | In distribution | |
| PRES0715CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0152HXP10 | In distribution | |
| PRES0620CPKPLT | PRESTIGE PLUS COMPLEX PACK 6mm x 20cm | In distribution |
| PRES3535CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0103HXPPL | In distribution | |
| PRES0520HPK10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0206HXP10 | In distribution | |
| PRES0358CXP10 | In distribution | |
| PRES0845CPKPLT | PRESTIGE PLUS COMPLEX PACK 8mm x 45cm | In distribution |
| PRES1345CPKPLT | PRESTIGE PLUS COMPLEX PACK 13mm x 45cm | In distribution |
| PRES0930CRG10 | In distribution | |
| PRES0253CXP10 | In distribution | |
| PRES0540HPKPL | PRESTIGE PLUS HELICAL PACK 5mm x 40cm | In distribution |
| PRES0154HXP10 | In distribution | |
| PRES0101CXP10 | In distribution | |
| PRES0406HXP10 | In distribution | |
| PRES0420HPK10 | In distribution | |
| PRES1665CPKPLT | PRESTIGE PLUS COMPLEX PACK 16mm x 65cm | In distribution |
| PRES0406CXP10 | In distribution | |
| PRES0204CPK10 | In distribution | |
| PRES0102HXPPL | In distribution | |
| PRES0720HPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1550CPKPL | In distribution | |
| PRES0152CXP10 | In distribution | |
| PRES0650CPKPLT | PRESTIGE PLUS COMPLEX PACK 6mm x 50cm | In distribution |
| PRES0103HXP10 | In distribution | |
| PRES1650CPKPL | In distribution | |
| PRES0358CXPPL | In distribution | |
| PRES0713CRG10 | In distribution | |
| PRES0507CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0153CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0204CXPPL | In distribution | |
| PRES0101HXP10 | In distribution | |
| PRES0308CPK10 | In distribution | |
| PRES0101HXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1065HPKPL | PRESTIGE PLUS HELICAL PACK 10mm x 65cm | In distribution |
| PRESPACK15 | Secondary Diameter x Length: 2mm x 15cm | In distribution |
| PRES0510HXP10 | In distribution | |
| PRES0153CXP10 | In distribution | |
| PRES0308CXP10 | In distribution | |
| PRES2525HXPPL | In distribution | |
| PRES1040CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0208HXPPL | In distribution | |
| PRES0520CPK10 | In distribution | |
| PRES1245CPKPL | In distribution | |
| PRES1027CRG10 | In distribution | |
| PRES0303CXPPL | In distribution | |
| PRES0407CRG10 | In distribution | |
| PRES0930HPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0208CPK10 | In distribution | |
| PRES0307CXPPL | In distribution | |
| PRES0206CPK10 | In distribution | |
| PRES0103HXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0930CPKPLT | PRESTIGE PLUS COMPLEX PACK 9mm x 30cm | In distribution |
| PRES0203HXP10 | In distribution | |
| PRES0413CPKPL | In distribution | |
| PRES0520CPK10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0620HPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1040CPKPL | In distribution | |
| PRES0513CXP10 | In distribution | |
| PRES1445CPKPL | In distribution | |
| PRES1040HPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0204HXPPL | In distribution | |
| PRES0417CPK10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0101HXPPL | In distribution | |
| PRES0611CPKPL | In distribution | |
| PRES0930CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0304CXP10 | In distribution | |
| PRES4545CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0306HXP10 | In distribution | |
| PRES0507CPKPL | In distribution | |
| PRES0724CPK10 | In distribution | |
| PRES0103CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES2265COM18 | In distribution | |
| PRES0827CPK10 | In distribution | |
| PRES0103CXP10 | In distribution | |
| PRES0413CRG10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES2525CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0715CPKPL | In distribution | |
| PRES0517CRG10 | In distribution | |
| PRES0255CPK10 | In distribution | |
| PRES0735CPKPLT | PRESTIGE PLUS COMPLEX PACK 7mm x 35cm | In distribution |
| PRES0816CPK10 | In distribution | |
| PRES0517CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0407CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES2465CPKPLT | PRESTIGE PLUS COMPLEX PACK 24mm x 65cm | In distribution |
| PRES0510HPK10 | In distribution | |
| PRES1565CPKPLT | PRESTIGE PLUS COMPLEX PACK 15mm x 65cm | In distribution |
| PRES0508CXP10 | In distribution | |
| PRES0520HPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0420CPKPLT | PRESTIGE PLUS COMPLEX PACK 4mm x 20cm | In distribution |
| PRES0203CXP10 | In distribution | |
| PRES1030CPKPL | In distribution | |
| PRES0304HXP10 | In distribution | |
| PRES1865CPKPLT | PRESTIGE PLUS COMPLEX PACK 18mm x 65cm | In distribution |
| PRES1860COM18 | In distribution | |
| PRES1655COM18 | In distribution | |
| PRES0615CPK10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1245CPKPLT | PRESTIGE PLUS COMPLEX PACK 12mm x 45cm | In distribution |
| PRES1265CPKPLT | PRESTIGE PLUS COMPLEX PACK 12mm x 65cm | In distribution |
| PRES0410CPKPL | In distribution | |
| PRES0154CXP10 | In distribution | |
| PRES4510CPKPL | In distribution | |
| PRES0506HPK10 | In distribution | |
| PRES0256HXP10 | In distribution | |
| PRES0830CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0820CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0412CXP10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0256CXP10 | In distribution | |
| PRES0203CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0830CPKPLT | PRESTIGE PLUS COMPLEX PACK 8mm x 30cm | In distribution |
| PRES0258CXPPLT | PRESTIGE PLUS COMPLEX XTRA PACK 2.5mm x 8cm | In distribution |
| PRES1515HXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0406HPK10 | In distribution | |
| PRES0510COM18 | In distribution | |
| PRES0151HXP10 | In distribution | |
| PRES0930COM18 | In distribution | |
| PRES0104HXP10 | In distribution | |
| PRES1650CPKPLT | PRESTIGE PLUS COMPLEX PACK 16mm x 50cm | In distribution |
| PRES0413CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0102HXP10 | In distribution | |
| PRES0615HRG10 | In distribution | |
| PRES0208CXP10 | In distribution | |
| PRES0356CPK10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1343COM18 | In distribution | |
| PRES0152CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0202CXP10 | In distribution | |
| PRES0310CXP10 | In distribution | |
| PRES3530CXPPLT | PRESTIGE PLUS COMPLEX XTRA PACK 3.5mm x 30cm | In distribution |
| PRESPACK65 | Secondary Diameter x Length: 2mm x 65cm | In distribution |
| PRES0611CPK10 | In distribution | |
| PRES0306CRG10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0203CPK10 | In distribution | |
| PRES1065CPKPLT | PRESTIGE PLUS COMPLEX PACK 10mm x 65cm | In distribution |
| PRES0204CXP10 | In distribution | |
| PRES0510COM18 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0830HPKPL | In distribution | |
| PRES0413CPKPLT | PRESTIGE PLUS COMPLEX PACK 4mm x 13cm | In distribution |
| PRES1550COM18 | In distribution | |
| PRES0865CPKPLT | PRESTIGE PLUS COMPLEX PACK 8mm x 65cm | In distribution |
| PRESPACK65V02 | Secondary Diameter x Length: 2mm x 65cm | In distribution |
| PRES0930HRG10 | In distribution | |
| PRES0254CXP10 | In distribution | |
| PRES0620CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0308HXP10 | In distribution | |
| PRES0306CPK10 | In distribution | |
| PRES0820HRG10 | In distribution | |
| PRES0540CPKPLT | PRESTIGE PLUS COMPLEX PACK 5mm x 40cm | In distribution |
| PRES0620CPKPL | In distribution | |
| PRES0610HPK10 | In distribution | |
| PRES0102HXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES1850CPKPL | In distribution | |
| PRES0310CXPPL | In distribution | |
| PRES0208CXPPLT | PRESTIGE PLUS COMPLEX XTRA PACK 2mm x 8cm | In distribution |
| PRES0308CRG10 | In distribution | |
| PRES0506HXP10 | In distribution | |
| PRES0152CXPPL | In distribution | |
| PRES0510CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0520HPK10 | In distribution | |
| PRES1030HRG10 | In distribution | |
| PRES0212CXPPLT | PRESTIGE PLUS COMPLEX XTRA PACK 2mm x 12cm | In distribution |
| PRES0102CXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0611CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0104CXP10 | In distribution | |
| PRES0720HRG10 | In distribution | |
| PRES1445CPKPLT | PRESTIGE PLUS COMPLEX PACK 14mm x 45cm | In distribution |
| PRES0440HPKPL | PRESTIGE PLUS HELICAL PACK 4mm x 40cm | In distribution |
| PRES0201HXP10 | In distribution | |
| PRES1515HXPPL | In distribution | |
| PRES0720CPKPLT | PRESTIGE PLUS COMPLEX PACK 7mm x 20cm | In distribution |
| PRES0520HPKPL | In distribution | |
| PRES0153CXPPL | In distribution | |
| PRES0210CXP10 | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0730HRG10 | In distribution | |
| PRES0310HXP10 | In distribution | |
| PRES0515HPKPL | In distribution | |
| PRES0930CPKPL | In distribution | |
| PRES0410HXP10 | In distribution | |
| PRES0304HPK10 | In distribution | |
| PRES0356CPK10 | In distribution | |
| PRES0305HXPPL | In distribution | |
| PRES0210CXP10 | In distribution | |
| PRES0720CPKPL | In distribution | |
| PRES2525HXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0606HPK10 | In distribution | |
| PRES0720CPKPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
| PRES0355CXPPL | In distribution | |
| PRES0435CPKPLT | PRESTIGE PLUS COMPLEX PACK 4mm x 35cm | In distribution |
| PRES0413CPK10 | In distribution | |
| PRES0611CRG10 | In distribution | |
| PRES1240COM18 | In distribution | |
| PRES0255HXPPL | PRESTIGE PLUS HELICAL XTRA PACK 1mm x 1cm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 279 |
| Optima Coil System | Balt USA, LLC | 255 |
| 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
2 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. | 1754 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 | 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.