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Angioplasty balloons

Jade PTA Balloon Dilatation Catheter

by OrbusNeich Medical (ShenZhen) 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 Jade PTA Balloon Dilatation Catheter

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Jade 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
551504012— Not statedAvailable
551512012— Not statedAvailable
551524012— Not statedAvailable
552001512— Not statedAvailable
552004012— Not statedAvailable
552006012— Not statedAvailable
552008012— Not statedAvailable
552018012— Not statedAvailable
552502012— Not statedAvailable
552508012— Not statedAvailable
552510012— Not statedAvailable
552512012— Not statedAvailable
552518012— Not statedAvailable
552524012— Not statedAvailable
553002012— Not statedAvailable
553006012— Not statedAvailable
553012012— Not statedAvailable
553015012— Not statedAvailable
553018012— Not statedAvailable
553502012— Not statedAvailable
553506012— Not statedAvailable
553515012— Not statedAvailable
553518012— Not statedAvailable
553524012— Not statedAvailable
554001512— Not statedAvailable
554002012— Not statedAvailable
554004012— Not statedAvailable
554006012— Not statedAvailable
554010012— Not statedAvailable
554012012— Not statedAvailable
554018012— Not statedAvailable
554512012— Not statedAvailable
555002012— Not statedAvailable
555004012— Not statedAvailable
555006012— Not statedAvailable
555010012— Not statedAvailable
555012012— Not statedAvailable
555018012— Not statedAvailable
555024012— Not statedAvailable
555502012— Not statedAvailable
555504012— Not statedAvailable
555508012— Not statedAvailable
555512012— Not statedAvailable
556002012— Not statedAvailable
556004012— Not statedAvailable
556006012— Not statedAvailable
556008012— Not statedAvailable
556010012— Not statedAvailable
556012012— Not statedAvailable
556015012— Not statedAvailable
556018012— Not statedAvailable
556024012— Not statedAvailable
557001512— Not statedAvailable
557002012— Not statedAvailable
557006012— Not statedAvailable
557008012— Not statedAvailable
557010012— Not statedAvailable
557015012— Not statedAvailable
581502012— Not statedAvailable
581502032— Not statedAvailable
581504012— Not statedAvailable
581504022— Not statedAvailable
581504032— Not statedAvailable
581508012— Not statedAvailable
581508022— Not statedAvailable
581508032— Not statedAvailable
581512032— Not statedAvailable
581518012— Not statedAvailable
581518022— Not statedAvailable
581524012— Not statedAvailable
581524022— Not statedAvailable
581524032— Not statedAvailable
582002012— Not statedAvailable
582002022— Not statedAvailable
582002032— Not statedAvailable
582004012— Not statedAvailable
582006012— Not statedAvailable
582006022— Not statedAvailable
582006032— Not statedAvailable
582008012— Not statedAvailable
582008022— Not statedAvailable
582012012— Not statedAvailable
582012032— Not statedAvailable
582015012— Not statedAvailable
582018012— Not statedAvailable
582018022— Not statedAvailable
582024012— Not statedAvailable
582024032— Not statedAvailable
582502012— Not statedAvailable
582504022— Not statedAvailable
582506012— Not statedAvailable
582506022— Not statedAvailable
582506032— Not statedAvailable
582508012— Not statedAvailable
582508022— Not statedAvailable
582508032— Not statedAvailable
582510012— Not statedAvailable
582512022— Not statedAvailable
582512032— Not statedAvailable
582515012— Not statedAvailable
582515022— Not statedAvailable
582515032— Not statedAvailable
582518012— Not statedAvailable
582518032— Not statedAvailable
582524022— Not statedAvailable
583002012— Not statedAvailable
583002022— Not statedAvailable
583002032— Not statedAvailable
583004012— Not statedAvailable
583004022— Not statedAvailable
583004032— Not statedAvailable
583006012— Not statedAvailable
583006022— Not statedAvailable
583006032— Not statedAvailable
583008022— Not statedAvailable
583010022— Not statedAvailable
583012012— Not statedAvailable
583012022— Not statedAvailable
583012032— Not statedAvailable
583015012— Not statedAvailable
583015032— Not statedAvailable
583018012— Not statedAvailable
583018022— Not statedAvailable
583024022— Not statedAvailable
583502022— Not statedAvailable
583502032— Not statedAvailable
583504022— Not statedAvailable
583506022— Not statedAvailable
583508032— Not statedAvailable
583510022— Not statedAvailable
583510032— Not statedAvailable
583512012— Not statedAvailable
583512022— Not statedAvailable
583512032— Not statedAvailable
583515022— Not statedAvailable
583518012— Not statedAvailable
583518032— Not statedAvailable
583524012— Not statedAvailable
583524022— Not statedAvailable
583524032— Not statedAvailable
584002012— Not statedAvailable
584002022— Not statedAvailable
584004012— Not statedAvailable
584004032— Not statedAvailable
584006012— Not statedAvailable
584006022— Not statedAvailable
584006032— Not statedAvailable
584008012— Not statedAvailable
584008022— Not statedAvailable
584008032— Not statedAvailable
584010012— Not statedAvailable
584010022— Not statedAvailable
584012012— Not statedAvailable
584012032— Not statedAvailable
584015012— Not statedAvailable
584015032— Not statedAvailable
584018012— Not statedAvailable
584018032— Not statedAvailable
584024012— Not statedAvailable
584024022— Not statedAvailable
584024032— Not statedAvailable
585002012— Not statedAvailable
585002022— Not statedAvailable
585002032— Not statedAvailable
585004012— Not statedAvailable
585004032— Not statedAvailable
585006012— Not statedAvailable
585006032— Not statedAvailable
585008012— Not statedAvailable
585010012— Not statedAvailable
585015012— Not statedAvailable
585018022— Not statedAvailable
585018032— Not statedAvailable
586002012— Not statedAvailable
586002022— Not statedAvailable
586002032— Not statedAvailable
586004022— Not statedAvailable
586006022— Not statedAvailable
586006032— Not statedAvailable
586008012— Not statedAvailable
586008022— Not statedAvailable
586010022— Not statedAvailable
586010032— Not statedAvailable
586012022— Not statedAvailable
586012032— Not statedAvailable
586015022— Not statedAvailable
586015032— Not statedAvailable
586018012— Not statedAvailable
586018022— Not statedAvailable
586024022— Not statedAvailable
591501522— Not statedAvailable
591502012— Not statedAvailable
591502032— Not statedAvailable
591504012— Not statedAvailable
591504032— Not statedAvailable
591508022— Not statedAvailable
591508032— Not statedAvailable
591512022— Not statedAvailable
591518022— Not statedAvailable
591518032— Not statedAvailable
592001522— Not statedAvailable
592001532— Not statedAvailable
592002022— Not statedAvailable
592002032— Not statedAvailable
592004012— Not statedAvailable
592004022— Not statedAvailable
592006022— Not statedAvailable
592008022— Not statedAvailable
592010012— Not statedAvailable
592010022— Not statedAvailable
592012012— Not statedAvailable
592012022— Not statedAvailable
592012032— Not statedAvailable
592015012— Not statedAvailable
592015022— Not statedAvailable
592018032— Not statedAvailable
592024012— Not statedAvailable
592024022— Not statedAvailable
592502012— Not statedAvailable
592504012— Not statedAvailable
592504032— Not statedAvailable
592506012— Not statedAvailable
592506032— Not statedAvailable
592508012— Not statedAvailable
592510012— Not statedAvailable
592510022— Not statedAvailable
592510032— Not statedAvailable
592512012— Not statedAvailable
592512032— Not statedAvailable
592518012— Not statedAvailable
592518022— Not statedAvailable
592518032— Not statedAvailable
592524012— Not statedAvailable
593001512— Not statedAvailable
593001522— Not statedAvailable
593001532— Not statedAvailable
593002022— Not statedAvailable
593002032— Not statedAvailable
593006012— Not statedAvailable
593006022— Not statedAvailable
593006032— Not statedAvailable
593008022— Not statedAvailable
593008032— Not statedAvailable
593010032— Not statedAvailable
593012012— Not statedAvailable
593012032— Not statedAvailable
593018022— Not statedAvailable
593018032— Not statedAvailable
593024012— Not statedAvailable
593024022— Not statedAvailable

FDA clearances

  • 510(k) K202231 December 2020
  • 510(k) K201794 July 2020

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 Jade 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 Jade PTA Balloon Dilatation Catheter?

Jade PTA Balloon Dilatation Catheter is made by OrbusNeich Medical (ShenZhen) Co., Ltd.. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Jade PTA Balloon Dilatation Catheter come in?

The FDA device database does not list sizes for Jade PTA Balloon Dilatation Catheter. Check the instructions for use or ask a OrbusNeich Medical (ShenZhen) Co., Ltd. representative.

Is Jade PTA Balloon Dilatation Catheter MRI safe?

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

Is Jade PTA Balloon Dilatation Catheter FDA cleared?

Jade PTA Balloon Dilatation Catheter is covered by FDA submissions K202231, K201794.

How do I contact a OrbusNeich Medical (ShenZhen) Co., Ltd. sales representative?

OrbusNeich Medical (ShenZhen) Co., Ltd. has not listed representatives on LA Vascular yet. Visit the OrbusNeich Medical (ShenZhen) 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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