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Angioplasty balloons

Falexpand HP 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 Falexpand HP PTA Balloon Dilatation Catheter

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Falexpand HP 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.SizeMRIStatus
KHP030020040— Not statedAvailable
KHP030020075— Not statedAvailable
KHP030020135— Not statedAvailable
KHP030030040— Not statedAvailable
KHP030030075— Not statedAvailable
KHP030030135— Not statedAvailable
KHP030040040— Not statedAvailable
KHP030040075— Not statedAvailable
KHP030040135— Not statedAvailable
KHP030060040— Not statedAvailable
KHP030060075— Not statedAvailable
KHP030060135— Not statedAvailable
KHP030080040— Not statedAvailable
KHP030080075— Not statedAvailable
KHP030080135— Not statedAvailable
KHP030100040— Not statedAvailable
KHP030100075— Not statedAvailable
KHP030100135— Not statedAvailable
KHP030120075— Not statedAvailable
KHP030120135— Not statedAvailable
KHP030150075— Not statedAvailable
KHP030150135— Not statedAvailable
KHP030180075— Not statedAvailable
KHP030180135— Not statedAvailable
KHP030200075— Not statedAvailable
KHP030200135— Not statedAvailable
KHP040020040— Not statedAvailable
KHP040020075— Not statedAvailable
KHP040020135— Not statedAvailable
KHP040030040— Not statedAvailable
KHP040030075— Not statedAvailable
KHP040030135— Not statedAvailable
KHP040040040— Not statedAvailable
KHP040040075— Not statedAvailable
KHP040040135— Not statedAvailable
KHP040060040— Not statedAvailable
KHP040060075— Not statedAvailable
KHP040060135— Not statedAvailable
KHP040080040— Not statedAvailable
KHP040080075— Not statedAvailable
KHP040080135— Not statedAvailable
KHP040100040— Not statedAvailable
KHP040100075— Not statedAvailable
KHP040100135— Not statedAvailable
KHP040120075— Not statedAvailable
KHP040120135— Not statedAvailable
KHP040150075— Not statedAvailable
KHP040150135— Not statedAvailable
KHP040180075— Not statedAvailable
KHP040180135— Not statedAvailable
KHP040200075— Not statedAvailable
KHP040200135— Not statedAvailable
KHP050020040— Not statedAvailable
KHP050020075— Not statedAvailable
KHP050020135— Not statedAvailable
KHP050030040— Not statedAvailable
KHP050030075— Not statedAvailable
KHP050030135— Not statedAvailable
KHP050040040— Not statedAvailable
KHP050040075— Not statedAvailable
KHP050040135— Not statedAvailable
KHP050060040— Not statedAvailable
KHP050060075— Not statedAvailable
KHP050060135— Not statedAvailable
KHP050080040— Not statedAvailable
KHP050080075— Not statedAvailable
KHP050080135— Not statedAvailable
KHP050100040— Not statedAvailable
KHP050100075— Not statedAvailable
KHP050100135— Not statedAvailable
KHP050120040— Not statedAvailable
KHP050120075— Not statedAvailable
KHP050120135— Not statedAvailable
KHP050150075— Not statedAvailable
KHP050150135— Not statedAvailable
KHP050180075— Not statedAvailable
KHP050180135— Not statedAvailable
KHP050200075— Not statedAvailable
KHP050200135— Not statedAvailable
KHP060020040— Not statedAvailable
KHP060020075— Not statedAvailable
KHP060020135— Not statedAvailable
KHP060030040— Not statedAvailable
KHP060030075— Not statedAvailable
KHP060030135— Not statedAvailable
KHP060040040— Not statedAvailable
KHP060040075— Not statedAvailable
KHP060040135— Not statedAvailable
KHP060060040— Not statedAvailable
KHP060060075— Not statedAvailable
KHP060060135— Not statedAvailable
KHP060080040— Not statedAvailable
KHP060080075— Not statedAvailable
KHP060080135— Not statedAvailable
KHP060100040— Not statedAvailable
KHP060100075— Not statedAvailable
KHP060100135— Not statedAvailable
KHP060120040— Not statedAvailable
KHP060120075— Not statedAvailable
KHP060120135— Not statedAvailable
KHP060150075— Not statedAvailable
KHP060150135— Not statedAvailable
KHP060180075— Not statedAvailable
KHP060180135— Not statedAvailable
KHP060200075— Not statedAvailable
KHP060200135— Not statedAvailable
KHP070020040— Not statedAvailable
KHP070020075— Not statedAvailable
KHP070020135— Not statedAvailable
KHP070030040— Not statedAvailable
KHP070030075— Not statedAvailable
KHP070030135— Not statedAvailable
KHP070040040— Not statedAvailable
KHP070040075— Not statedAvailable
KHP070040135— Not statedAvailable
KHP070060040— Not statedAvailable
KHP070060075— Not statedAvailable
KHP070060135— Not statedAvailable
KHP070080040— Not statedAvailable
KHP070080075— Not statedAvailable
KHP070080135— Not statedAvailable
KHP070100040— Not statedAvailable
KHP070100075— Not statedAvailable
KHP070100135— Not statedAvailable
KHP070120075— Not statedAvailable
KHP070120135— Not statedAvailable
KHP070150075— Not statedAvailable
KHP070150135— Not statedAvailable
KHP070180075— Not statedAvailable
KHP070180135— Not statedAvailable
KHP070200075— Not statedAvailable
KHP070200135— Not statedAvailable
KHP080020040— Not statedAvailable
KHP080020075— Not statedAvailable
KHP080020135— Not statedAvailable
KHP080030040— Not statedAvailable
KHP080030075— Not statedAvailable
KHP080030135— Not statedAvailable
KHP080040040— Not statedAvailable
KHP080040075— Not statedAvailable
KHP080040135— Not statedAvailable
KHP080060040— Not statedAvailable
KHP080060075— Not statedAvailable
KHP080060135— Not statedAvailable
KHP080080040— Not statedAvailable
KHP080080075— Not statedAvailable
KHP080080135— Not statedAvailable
KHP080100040— Not statedAvailable
KHP080100075— Not statedAvailable
KHP080100135— Not statedAvailable
KHP080120075— Not statedAvailable
KHP080120135— Not statedAvailable
KHP080150075— Not statedAvailable
KHP080150135— Not statedAvailable
KHP080180075— Not statedAvailable
KHP080180135— Not statedAvailable
KHP080200075— Not statedAvailable
KHP080200135— Not statedAvailable
KHP090020040— Not statedAvailable
KHP090020075— Not statedAvailable
KHP090020135— Not statedAvailable
KHP090030040— Not statedAvailable
KHP090030075— Not statedAvailable
KHP090030135— Not statedAvailable
KHP090040040— Not statedAvailable
KHP090040075— Not statedAvailable
KHP090040135— Not statedAvailable
KHP090060040— Not statedAvailable
KHP090060075— Not statedAvailable
KHP090060135— Not statedAvailable
KHP090080040— Not statedAvailable
KHP090080075— Not statedAvailable
KHP090080135— Not statedAvailable
KHP100020040— Not statedAvailable
KHP100020075— Not statedAvailable
KHP100020135— Not statedAvailable
KHP100030040— Not statedAvailable
KHP100030075— Not statedAvailable
KHP100030135— Not statedAvailable
KHP100040040— Not statedAvailable
KHP100040075— Not statedAvailable
KHP100040135— Not statedAvailable
KHP100060040— Not statedAvailable
KHP100060075— Not statedAvailable
KHP100060135— Not statedAvailable
KHP100080040— Not statedAvailable
KHP100080075— Not statedAvailable
KHP100080135— Not statedAvailable
KHP120020040— Not statedAvailable
KHP120020075— Not statedAvailable
KHP120020135— Not statedAvailable
KHP120030040— Not statedAvailable
KHP120030075— Not statedAvailable
KHP120030135— Not statedAvailable
KHP120040040— Not statedAvailable
KHP120040075— Not statedAvailable
KHP120040135— Not statedAvailable
KHP120060040— Not statedAvailable
KHP120060075— Not statedAvailable
KHP120060135— Not statedAvailable
KHP120080040— Not statedAvailable
KHP120080075— Not statedAvailable
KHP120080135— Not statedAvailable

FDA clearances

  • 510(k) K231402 December 2023

Procedures that use angioplasty balloons

DVT Mechanical ThrombectomyVenous Stenting (Iliac and Central Veins)Peripheral Balloon AngioplastyPeripheral Artery StentingPeripheral AtherectomyFistulogram with AngioplastyDialysis Graft and Fistula ThrombectomyTIPS (Transjugular Intrahepatic Portosystemic Shunt)

Frequently asked questions

What is Falexpand HP 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 Falexpand HP PTA Balloon Dilatation Catheter?

Falexpand HP 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 Falexpand HP PTA Balloon Dilatation Catheter come in?

The FDA device database does not list sizes for Falexpand HP PTA Balloon Dilatation Catheter. Check the instructions for use or ask a Kossel Medtech (Suzhou) Co., Ltd. representative.

Is Falexpand HP PTA Balloon Dilatation Catheter MRI safe?

The FDA device database entry for Falexpand HP PTA Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.

Is Falexpand HP PTA Balloon Dilatation Catheter FDA cleared?

Falexpand HP PTA Balloon Dilatation Catheter is covered by FDA submission 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.

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