Angioplasty balloons
Falspeed PTA Balloon Dilatation Catheter
by Kossel Medtech (Suzhou) Co., Ltd.
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
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Where to buy Falspeed PTA Balloon Dilatation Catheter
Contact Kossel Medtech (Suzhou) Co., Ltd. directly; they can quote, ship, or point you to the distributor for your country.
From kossel-medical.com, checked October 2026.
No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.
Falspeed PTA Balloon Dilatation Catheter models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| KPTA20020S | — | Not stated | Available |
| KPTA20030L | — | Not stated | Available |
| KPTA20030S | — | Not stated | Available |
| KPTA20040L | — | Not stated | Available |
| KPTA20040S | — | Not stated | Available |
| KPTA20060L | — | Not stated | Available |
| KPTA20060S | — | Not stated | Available |
| KPTA20080L | — | Not stated | Available |
| KPTA20080S | — | Not stated | Available |
| KPTA20100L | — | Not stated | Available |
| KPTA20100S | — | Not stated | Available |
| KPTA20120L | — | Not stated | Available |
| KPTA20120S | — | Not stated | Available |
| KPTA20150L | — | Not stated | Available |
| KPTA20150S | — | Not stated | Available |
| KPTA20200L | — | Not stated | Available |
| KPTA20200S | — | Not stated | Available |
| KPTA20250L | — | Not stated | Available |
| KPTA20250S | — | Not stated | Available |
| KPTA20300L | — | Not stated | Available |
| KPTA20300S | — | Not stated | Available |
| KPTA25020L | — | Not stated | Available |
| KPTA25020S | — | Not stated | Available |
| KPTA25030L | — | Not stated | Available |
| KPTA25030S | — | Not stated | Available |
| KPTA25040L | — | Not stated | Available |
| KPTA25040S | — | Not stated | Available |
| KPTA25060L | — | Not stated | Available |
| KPTA25060S | — | Not stated | Available |
| KPTA25080L | — | Not stated | Available |
| KPTA25080S | — | Not stated | Available |
| KPTA25100L | — | Not stated | Available |
| KPTA25100S | — | Not stated | Available |
| KPTA25120L | — | Not stated | Available |
| KPTA25120S | — | Not stated | Available |
| KPTA25150L | — | Not stated | Available |
| KPTA25150S | — | Not stated | Available |
| KPTA25200L | — | Not stated | Available |
| KPTA25200S | — | Not stated | Available |
| KPTA25250L | — | Not stated | Available |
| KPTA25250S | — | Not stated | Available |
| KPTA25300L | — | Not stated | Available |
| KPTA25300S | — | Not stated | Available |
| KPTA30020L | — | Not stated | Available |
| KPTA30020S | — | Not stated | Available |
| KPTA30030L | — | Not stated | Available |
| KPTA30030S | — | Not stated | Available |
| KPTA30040L | — | Not stated | Available |
| KPTA30040S | — | Not stated | Available |
| KPTA30060L | — | Not stated | Available |
| KPTA30060S | — | Not stated | Available |
| KPTA30080L | — | Not stated | Available |
| KPTA30080S | — | Not stated | Available |
| KPTA30100L | — | Not stated | Available |
| KPTA30100S | — | Not stated | Available |
| KPTA30120L | — | Not stated | Available |
| KPTA30120S | — | Not stated | Available |
| KPTA30150L | — | Not stated | Available |
| KPTA30150S | — | Not stated | Available |
| KPTA30200L | — | Not stated | Available |
| KPTA30200S | — | Not stated | Available |
| KPTA30250L | — | Not stated | Available |
| KPTA30250S | — | Not stated | Available |
| KPTA30300L | — | Not stated | Available |
| KPTA30300S | — | Not stated | Available |
| KPTA35020L | — | Not stated | Available |
| KPTA35020S | — | Not stated | Available |
| KPTA35030L | — | Not stated | Available |
| KPTA35030S | — | Not stated | Available |
| KPTA35040L | — | Not stated | Available |
| KPTA35040S | — | Not stated | Available |
| KPTA35060L | — | Not stated | Available |
| KPTA35060S | — | Not stated | Available |
| KPTA35080L | — | Not stated | Available |
| KPTA35080S | — | Not stated | Available |
| KPTA35100L | — | Not stated | Available |
| KPTA35100S | — | Not stated | Available |
| KPTA35120L | — | Not stated | Available |
| KPTA35120S | — | Not stated | Available |
| KPTA35150L | — | Not stated | Available |
| KPTA35150S | — | Not stated | Available |
| KPTA35200L | — | Not stated | Available |
| KPTA35200S | — | Not stated | Available |
| KPTA35250L | — | Not stated | Available |
| KPTA35250S | — | Not stated | Available |
| KPTA35300L | — | Not stated | Available |
| KPTA35300S | — | Not stated | Available |
| KPTA40020L | — | Not stated | Available |
| KPTA40020S | — | Not stated | Available |
| KPTA40030L | — | Not stated | Available |
| KPTA40030S | — | Not stated | Available |
| KPTA40040L | — | Not stated | Available |
| KPTA40040S | — | Not stated | Available |
| KPTA40060L | — | Not stated | Available |
| KPTA40060S | — | Not stated | Available |
| KPTA40080L | — | Not stated | Available |
| KPTA40080S | — | Not stated | Available |
| KPTA40100L | — | Not stated | Available |
| KPTA40100S | — | Not stated | Available |
| KPTA40120L | — | Not stated | Available |
| KPTA40120S | — | Not stated | Available |
| KPTA40150L | — | Not stated | Available |
| KPTA40150S | — | Not stated | Available |
| KPTA40200L | — | Not stated | Available |
| KPTA40200S | — | Not stated | Available |
| KPTA40250L | — | Not stated | Available |
| KPTA40250S | — | Not stated | Available |
| KPTA40300L | — | Not stated | Available |
| KPTA40300S | — | Not stated | Available |
| KPTA50020L | — | Not stated | Available |
| KPTA50020S | — | Not stated | Available |
| KPTA50030L | — | Not stated | Available |
| KPTA50030S | — | Not stated | Available |
| KPTA50040L | — | Not stated | Available |
| KPTA50040S | — | Not stated | Available |
| KPTA50060L | — | Not stated | Available |
| KPTA50060S | — | Not stated | Available |
| KPTA50080L | — | Not stated | Available |
| KPTA50080S | — | Not stated | Available |
| KPTA50100L | — | Not stated | Available |
| KPTA50100S | — | Not stated | Available |
| KPTA50120L | — | Not stated | Available |
| KPTA50120S | — | Not stated | Available |
| KPTA50150L | — | Not stated | Available |
| KPTA50150S | — | Not stated | Available |
| KPTA50200L | — | Not stated | Available |
| KPTA50200S | — | Not stated | Available |
| KPTA50250L | — | Not stated | Available |
| KPTA50250S | — | Not stated | Available |
| KPTA50300L | — | Not stated | Available |
| KPTA50300S | — | Not stated | Available |
| KPTA60020L | — | Not stated | Available |
| KPTA60020S | — | Not stated | Available |
| KPTA60030L | — | Not stated | Available |
| KPTA60030S | — | Not stated | Available |
| KPTA60040L | — | Not stated | Available |
| KPTA60040S | — | Not stated | Available |
| KPTA60060L | — | Not stated | Available |
| KPTA60060S | — | Not stated | Available |
| KPTA60080L | — | Not stated | Available |
| KPTA60080S | — | Not stated | Available |
| KPTA60100L | — | Not stated | Available |
| KPTA60100S | — | Not stated | Available |
| KPTA60120L | — | Not stated | Available |
| KPTA60120S | — | Not stated | Available |
| KPTA60150L | — | Not stated | Available |
| KPTA60150S | — | Not stated | Available |
| KPTA60200L | — | Not stated | Available |
| KPTA60200S | — | Not stated | Available |
| KPTA60250L | — | Not stated | Available |
| KPTA60250S | — | Not stated | Available |
| KPTA60300L | — | Not stated | Available |
| KPTA60300S | — | Not stated | Available |
| KPTA70020L | — | Not stated | Available |
| KPTA70020S | — | Not stated | Available |
| KPTA70030L | — | Not stated | Available |
| KPTA70030S | — | Not stated | Available |
| KPTA70040L | — | Not stated | Available |
| KPTA70040S | — | Not stated | Available |
| KPTA70060L | — | Not stated | Available |
| KPTA70060S | — | Not stated | Available |
| KPTA70080L | — | Not stated | Available |
| KPTA70080S | — | Not stated | Available |
| KPTA70100L | — | Not stated | Available |
| KPTA70100S | — | Not stated | Available |
| KPTA70120L | — | Not stated | Available |
| KPTA70120S | — | Not stated | Available |
| KPTA70150L | — | Not stated | Available |
| KPTA70150S | — | Not stated | Available |
| KPTA70200L | — | Not stated | Available |
| KPTA70200S | — | Not stated | Available |
| KPTA70250L | — | Not stated | Available |
| KPTA70250S | — | Not stated | Available |
| KPTA70300L | — | Not stated | Available |
| KPTA70300S | — | Not stated | Available |
FDA clearances
- 510(k) K231402 December 2023
- 510(k) K221245 December 2022
Procedures that use angioplasty balloons
Frequently asked questions
What is Falspeed PTA Balloon Dilatation Catheter used for?
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Who makes Falspeed PTA Balloon Dilatation Catheter?
Falspeed PTA Balloon Dilatation Catheter is made by Kossel Medtech (Suzhou) Co., Ltd.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Falspeed PTA Balloon Dilatation Catheter come in?
The FDA device database does not list sizes for Falspeed PTA Balloon Dilatation Catheter. Check the instructions for use or ask a Kossel Medtech (Suzhou) Co., Ltd. representative.
Is Falspeed PTA Balloon Dilatation Catheter MRI safe?
The FDA device database entry for Falspeed PTA Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Falspeed PTA Balloon Dilatation Catheter FDA cleared?
Falspeed PTA Balloon Dilatation Catheter is covered by FDA submissions K221245, K231402.
How do I contact a Kossel Medtech (Suzhou) Co., Ltd. sales representative?
Kossel Medtech (Suzhou) Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Kossel Medtech (Suzhou) Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.