Angioplasty balloons

PTA High Pressure Balloon Dilatation Catheter

by DK Medical Technology 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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PTA High Pressure 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
HPA50-3020A5β€” Not statedAvailable
HPA50-3030A5β€” Not statedAvailable
HPA50-3040A5β€” Not statedAvailable
HPA50-3060A5β€” Not statedAvailable
HPA50-3080A5β€” Not statedAvailable
HPA50-4020A5β€” Not statedAvailable
HPA50-4030A5β€” Not statedAvailable
HPA50-4040A5β€” Not statedAvailable
HPA50-4060A5β€” Not statedAvailable
HPA50-4080A5β€” Not statedAvailable
HPA50-5020A5β€” Not statedAvailable
HPA50-5030A5β€” Not statedAvailable
HPA50-5040A5β€” Not statedAvailable
HPA50-5060A5β€” Not statedAvailable
HPA50-5080A5β€” Not statedAvailable
HPA50-6020A5β€” Not statedAvailable
HPA50-6030A5β€” Not statedAvailable
HPA50-6040A5β€” Not statedAvailable
HPA50-6060A5β€” Not statedAvailable
HPA50-6080A5β€” Not statedAvailable
HPA50-7020A5β€” Not statedAvailable
HPA50-7030A5β€” Not statedAvailable
HPA50-7040A5β€” Not statedAvailable
HPA50-7060A5β€” Not statedAvailable
HPA50-7080A5β€” Not statedAvailable
HPA50-8020A6β€” Not statedAvailable
HPA50-8030A6β€” Not statedAvailable
HPA50-8040A6β€” Not statedAvailable
HPA50-8060A6β€” Not statedAvailable
HPA50-8080A6β€” Not statedAvailable
HPA50-9020A6β€” Not statedAvailable
HPA50-9030A6β€” Not statedAvailable
HPA50-9040A6β€” Not statedAvailable
HPA50-9060A6β€” Not statedAvailable
HPA50-9080A6β€” Not statedAvailable
HPA50-10020A6β€” Not statedAvailable
HPA50-10030A6β€” Not statedAvailable
HPA50-10040A6β€” Not statedAvailable
HPA50-10060A6β€” Not statedAvailable
HPA50-10080A6β€” Not statedAvailable
HPA50-12020A7β€” Not statedAvailable
HPA50-12030A7β€” Not statedAvailable
HPA50-12040A7β€” Not statedAvailable
HPA50-12060A7β€” Not statedAvailable
HPA50-12080A7β€” Not statedAvailable
HPA50-30100A5β€” Not statedAvailable
HPA50-30120A5β€” Not statedAvailable
HPA50-30150A5β€” Not statedAvailable
HPA50-40100A5β€” Not statedAvailable
HPA50-40120A5β€” Not statedAvailable
HPA50-40150A5β€” Not statedAvailable
HPA50-50100A5β€” Not statedAvailable
HPA50-50120A5β€” Not statedAvailable
HPA50-50150A5β€” Not statedAvailable
HPA50-60100A5β€” Not statedAvailable
HPA50-60120A5β€” Not statedAvailable
HPA50-60150A5β€” Not statedAvailable
HPA50-70100A5β€” Not statedAvailable
HPA50-70120A5β€” Not statedAvailable
HPA50-70150A5β€” Not statedAvailable
HPA50-80100A6β€” Not statedAvailable
HPA50-80120A6β€” Not statedAvailable
HPA50-80150A6β€” Not statedAvailable
HPA75-3020B5β€” Not statedAvailable
HPA75-3030B5β€” Not statedAvailable
HPA75-3040B5β€” Not statedAvailable
HPA75-3060B5β€” Not statedAvailable
HPA75-3080B5β€” Not statedAvailable
HPA75-4020B5β€” Not statedAvailable
HPA75-4030B5β€” Not statedAvailable
HPA75-4040B5β€” Not statedAvailable
HPA75-4060B5β€” Not statedAvailable
HPA75-4080B5β€” Not statedAvailable
HPA75-5020B5β€” Not statedAvailable
HPA75-5030B5β€” Not statedAvailable
HPA75-5040B5β€” Not statedAvailable
HPA75-5060B5β€” Not statedAvailable
HPA75-5080B5β€” Not statedAvailable
HPA75-6020B5β€” Not statedAvailable
HPA75-6030B5β€” Not statedAvailable
HPA75-6040B5β€” Not statedAvailable
HPA75-6060B5β€” Not statedAvailable
HPA75-6080B5β€” Not statedAvailable
HPA75-7020B5β€” Not statedAvailable
HPA75-7030B5β€” Not statedAvailable
HPA75-7040B5β€” Not statedAvailable
HPA75-7060B5β€” Not statedAvailable
HPA75-7080B5β€” Not statedAvailable
HPA75-8020B6β€” Not statedAvailable
HPA75-8030B6β€” Not statedAvailable
HPA75-8040B6β€” Not statedAvailable
HPA75-8060B6β€” Not statedAvailable
HPA75-8080B6β€” Not statedAvailable
HPA75-9020B6β€” Not statedAvailable
HPA75-9030B6β€” Not statedAvailable
HPA75-9040B6β€” Not statedAvailable
HPA75-9060B6β€” Not statedAvailable
HPA75-9080B6β€” Not statedAvailable
HPA75-10020B6β€” Not statedAvailable
HPA75-10030B6β€” Not statedAvailable
HPA75-10040B6β€” Not statedAvailable
HPA75-10060B6β€” Not statedAvailable
HPA75-10080B6β€” Not statedAvailable
HPA75-12020B7β€” Not statedAvailable
HPA75-12030B7β€” Not statedAvailable
HPA75-12040B7β€” Not statedAvailable
HPA75-12060B7β€” Not statedAvailable
HPA75-12080B7β€” Not statedAvailable
HPA75-30100B5β€” Not statedAvailable
HPA75-30120B5β€” Not statedAvailable
HPA75-30150B5β€” Not statedAvailable
HPA75-40100B5β€” Not statedAvailable
HPA75-40120B5β€” Not statedAvailable
HPA75-40150B5β€” Not statedAvailable
HPA75-50100B5β€” Not statedAvailable
HPA75-50120B5β€” Not statedAvailable
HPA75-50150B5β€” Not statedAvailable
HPA75-60100B5β€” Not statedAvailable
HPA75-60120B5β€” Not statedAvailable
HPA75-60150B5β€” Not statedAvailable
HPA75-70100B5β€” Not statedAvailable
HPA75-70120B5β€” Not statedAvailable
HPA75-70150B5β€” Not statedAvailable
HPA75-80100B6β€” Not statedAvailable
HPA75-80120B6β€” Not statedAvailable
HPA75-80150B6β€” Not statedAvailable
HPA130-3020C5β€” Not statedAvailable
HPA130-3030C5β€” Not statedAvailable
HPA130-3040C5β€” Not statedAvailable
HPA130-3060C5β€” Not statedAvailable
HPA130-3080C5β€” Not statedAvailable
HPA130-4020C5β€” Not statedAvailable
HPA130-4030C5β€” Not statedAvailable
HPA130-4040C5β€” Not statedAvailable
HPA130-4060C5β€” Not statedAvailable
HPA130-4080C5β€” Not statedAvailable
HPA130-5020C5β€” Not statedAvailable
HPA130-5030C5β€” Not statedAvailable
HPA130-5040C5β€” Not statedAvailable
HPA130-5060C5β€” Not statedAvailable
HPA130-5080C5β€” Not statedAvailable
HPA130-6020C5β€” Not statedAvailable
HPA130-6030C5β€” Not statedAvailable
HPA130-6040C5β€” Not statedAvailable
HPA130-6060C5β€” Not statedAvailable
HPA130-6080C5β€” Not statedAvailable
HPA130-7020C5β€” Not statedAvailable
HPA130-7030C5β€” Not statedAvailable
HPA130-7040C5β€” Not statedAvailable
HPA130-7060C5β€” Not statedAvailable
HPA130-7080C5β€” Not statedAvailable
HPA130-8020C6β€” Not statedAvailable
HPA130-8030C6β€” Not statedAvailable
HPA130-8040C6β€” Not statedAvailable
HPA130-8060C6β€” Not statedAvailable
HPA130-8080C6β€” Not statedAvailable
HPA130-9020C6β€” Not statedAvailable
HPA130-9030C6β€” Not statedAvailable
HPA130-9040C6β€” Not statedAvailable
HPA130-9060C6β€” Not statedAvailable
HPA130-9080C6β€” Not statedAvailable
HPA130-10020C6β€” Not statedAvailable
HPA130-10030C6β€” Not statedAvailable
HPA130-10040C6β€” Not statedAvailable
HPA130-10060C6β€” Not statedAvailable
HPA130-10080C6β€” Not statedAvailable
HPA130-12020C7β€” Not statedAvailable
HPA130-12030C7β€” Not statedAvailable
HPA130-12040C7β€” Not statedAvailable
HPA130-12060C7β€” Not statedAvailable
HPA130-12080C7β€” Not statedAvailable
HPA130-30100C5β€” Not statedAvailable
HPA130-30120C5β€” Not statedAvailable
HPA130-30150C5β€” Not statedAvailable
HPA130-40100C5β€” Not statedAvailable
HPA130-40120C5β€” Not statedAvailable
HPA130-40150C5β€” Not statedAvailable
HPA130-50100C5β€” Not statedAvailable
HPA130-50120C5β€” Not statedAvailable
HPA130-50150C5β€” Not statedAvailable
HPA130-60100C5β€” Not statedAvailable
HPA130-60120C5β€” Not statedAvailable
HPA130-60150C5β€” Not statedAvailable
HPA130-70100C5β€” Not statedAvailable
HPA130-70120C5β€” Not statedAvailable
HPA130-70150C5β€” Not statedAvailable
HPA130-80100C6β€” Not statedAvailable
HPA130-80120C6β€” Not statedAvailable
HPA130-80150C6β€” Not statedAvailable

FDA clearances

  • 510(k) K214009 April 2023

Procedures that use angioplasty balloons

Frequently asked questions

What is PTA High Pressure 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 PTA High Pressure Balloon Dilatation Catheter?

PTA High Pressure Balloon Dilatation Catheter is made by DK Medical Technology Co., Ltd.. It is listed under peripheral angioplasty balloons in our device library.

What sizes does PTA High Pressure Balloon Dilatation Catheter come in?

The FDA device database does not list sizes for PTA High Pressure Balloon Dilatation Catheter. Check the instructions for use or ask a DK Medical Technology Co., Ltd. representative.

Is PTA High Pressure Balloon Dilatation Catheter MRI safe?

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

Is PTA High Pressure Balloon Dilatation Catheter FDA cleared?

PTA High Pressure Balloon Dilatation Catheter is covered by FDA submission K214009.

How do I contact a DK Medical Technology Co., Ltd. sales representative?

DK Medical Technology Co., Ltd. has not listed representatives on LA Vascular yet. Visit the DK Medical Technology 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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