Falspeed PTA Balloon Dilatation Catheter
Falspeed PTA Balloon Dilatation Catheter is an over-the-wire device for dilating narrowed peripheral vessels. Its nylon balloon expands under applied pressure, with a soft distal tip for…
Falspeed PTA Balloon Dilatation Catheter is an over-the-wire device for dilating narrowed peripheral vessels. Its nylon balloon expands under applied pressure, with a soft distal tip for advancement and two marker bands to identify balloon position under external imaging. The catheter has a hydrophilic coating.
Indications include angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries, plus obstructive lesions in native or synthetic arteriovenous dialysis fistulas. The guidewire channel accepts a 0.018-inch wire, and the catheter is compatible with a 6 Fr sheath.
Balloon and Shaft Range
Subject balloon diameters range from 2 to 7 mm and balloon lengths from 20 to 300 mm. Catheter working lengths are 90 or 150 cm. The hub connects to external inflation equipment, while strain-relief tubing protects the shaft from bending. The device is sterilized with ethylene oxide.
5manufacturers in China registered for this device type
176catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Kossel Medtech (Suzhou) Co., Ltd., China |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer |
| 510(k) | K221245 |
| Record published | 2026-04-28 |
| Record revised | 2026-05-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KPTA25030S | In distribution | |
| KPTA40060S | In distribution | |
| KPTA70030L | In distribution | |
| KPTA50100S | In distribution | |
| KPTA40250S | In distribution | |
| KPTA35150L | In distribution | |
| KPTA25250L | In distribution | |
| KPTA70120S | In distribution | |
| KPTA35020L | In distribution | |
| KPTA20060S | In distribution | |
| KPTA50250L | In distribution | |
| KPTA70250L | In distribution | |
| KPTA70020S | In distribution | |
| KPTA30060S | In distribution | |
| KPTA35060L | In distribution | |
| KPTA35080S | In distribution | |
| KPTA35200L | In distribution | |
| KPTA70020L | In distribution | |
| KPTA35120L | In distribution | |
| KPTA40080S | In distribution | |
| KPTA25300L | In distribution | |
| KPTA30060L | In distribution | |
| KPTA30080S | In distribution | |
| KPTA50300S | In distribution | |
| KPTA70150S | In distribution | |
| KPTA20030S | In distribution | |
| KPTA30120L | In distribution | |
| KPTA30150S | In distribution | |
| KPTA30100L | In distribution | |
| KPTA50030L | In distribution | |
| KPTA20200L | In distribution | |
| KPTA40120L | In distribution | |
| KPTA30040S | In distribution | |
| KPTA35120S | In distribution | |
| KPTA40020L | In distribution | |
| KPTA40100S | In distribution | |
| KPTA40200S | In distribution | |
| KPTA35200S | In distribution | |
| KPTA60080S | In distribution | |
| KPTA35300L | In distribution | |
| KPTA35020S | In distribution | |
| KPTA50120L | In distribution | |
| KPTA50300L | In distribution | |
| KPTA60080L | In distribution | |
| KPTA35150S | In distribution | |
| KPTA60030S | In distribution | |
| KPTA20080L | In distribution | |
| KPTA25100S | In distribution | |
| KPTA20300S | In distribution | |
| KPTA35250L | In distribution | |
| KPTA20020S | In distribution | |
| KPTA60100L | In distribution | |
| KPTA70300L | In distribution | |
| KPTA70080S | In distribution | |
| KPTA40250L | In distribution | |
| KPTA50100L | In distribution | |
| KPTA60020L | In distribution | |
| KPTA60120L | In distribution | |
| KPTA25060L | In distribution | |
| KPTA20150S | In distribution | |
| KPTA60300L | In distribution | |
| KPTA60200L | In distribution | |
| KPTA60250L | In distribution | |
| KPTA20080S | In distribution | |
| KPTA20300L | In distribution | |
| KPTA30120S | In distribution | |
| KPTA35250S | In distribution | |
| KPTA70060S | In distribution | |
| KPTA40150L | In distribution | |
| KPTA25200L | In distribution | |
| KPTA70100L | In distribution | |
| KPTA70250S | In distribution | |
| KPTA25080L | In distribution | |
| KPTA25300S | In distribution | |
| KPTA25100L | In distribution | |
| KPTA35100S | In distribution | |
| KPTA60040L | In distribution | |
| KPTA20040S | In distribution | |
| KPTA30150L | In distribution | |
| KPTA25030L | In distribution | |
| KPTA20020L | In distribution | |
| KPTA35300S | In distribution | |
| KPTA60150L | In distribution | |
| KPTA40020S | In distribution | |
| KPTA70300S | In distribution | |
| KPTA50200L | In distribution | |
| KPTA25060S | In distribution | |
| KPTA20120S | In distribution | |
| KPTA30030L | In distribution | |
| KPTA30200L | In distribution | |
| KPTA30250S | In distribution | |
| KPTA25250S | In distribution | |
| KPTA30020L | In distribution | |
| KPTA30100S | In distribution | |
| KPTA40150S | In distribution | |
| KPTA40120S | In distribution | |
| KPTA25150S | In distribution | |
| KPTA30250L | In distribution | |
| KPTA20100S | In distribution | |
| KPTA70040L | In distribution | |
| KPTA60030L | In distribution | |
| KPTA40080L | In distribution | |
| KPTA20150L | In distribution | |
| KPTA50020S | In distribution | |
| KPTA25040L | In distribution | |
| KPTA25120S | In distribution | |
| KPTA50040L | In distribution | |
| KPTA50060S | In distribution | |
| KPTA35040L | In distribution | |
| KPTA30080L | In distribution | |
| KPTA20250L | In distribution | |
| KPTA35030S | In distribution | |
| KPTA40200L | In distribution | |
| KPTA30040L | In distribution | |
| KPTA70150L | In distribution | |
| KPTA20030L | In distribution | |
| KPTA35030L | In distribution | |
| KPTA50020L | In distribution | |
| KPTA60150S | In distribution | |
| KPTA70100S | In distribution | |
| KPTA30030S | In distribution | |
| KPTA60040S | In distribution | |
| KPTA30020S | In distribution | |
| KPTA20040L | In distribution | |
| KPTA70060L | In distribution | |
| KPTA40040L | In distribution | |
| KPTA50080L | In distribution | |
| KPTA60060S | In distribution | |
| KPTA50120S | In distribution | |
| KPTA70080L | In distribution | |
| KPTA25080S | In distribution | |
| KPTA40030S | In distribution | |
| KPTA70030S | In distribution | |
| KPTA20120L | In distribution | |
| KPTA70200S | In distribution | |
| KPTA20100L | In distribution | |
| KPTA60020S | In distribution | |
| KPTA30300L | In distribution | |
| KPTA60100S | In distribution | |
| KPTA40100L | In distribution | |
| KPTA25020S | In distribution | |
| KPTA50200S | In distribution | |
| KPTA25020L | In distribution | |
| KPTA50250S | In distribution | |
| KPTA40030L | In distribution | |
| KPTA35060S | In distribution | |
| KPTA60200S | In distribution | |
| KPTA40300L | In distribution | |
| KPTA20200S | In distribution | |
| KPTA50030S | In distribution | |
| KPTA25040S | In distribution | |
| KPTA70040S | In distribution | |
| KPTA50150L | In distribution | |
| KPTA40300S | In distribution | |
| KPTA40040S | In distribution | |
| KPTA30300S | In distribution | |
| KPTA20250S | In distribution | |
| KPTA60120S | In distribution | |
| KPTA25120L | In distribution | |
| KPTA35080L | In distribution | |
| KPTA60060L | In distribution | |
| KPTA60300S | In distribution | |
| KPTA35100L | In distribution | |
| KPTA60250S | In distribution | |
| KPTA50150S | In distribution | |
| KPTA40060L | In distribution | |
| KPTA20060L | In distribution | |
| KPTA25150L | In distribution | |
| KPTA25200S | In distribution | |
| KPTA70200L | In distribution | |
| KPTA70120L | In distribution | |
| KPTA30200S | In distribution | |
| KPTA35040S | In distribution | |
| KPTA50060L | In distribution | |
| KPTA50080S | In distribution | |
| KPTA50040S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231402 | 2023-12-20 |
| K221245 | 2022-12-14 |
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.