Angioplasty balloons

Cronus HP - OTW PTA BALLOON CATHETER

by Nipro Medical Corporation

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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Cronus HP - OTW PTA BALLOON CATHETER models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
NCH+42045β€” Not statedAvailable
NCH+42080β€” Not statedAvailable
NCH+43045β€” Not statedAvailable
NCH+43080β€” Not statedAvailable
NCH+44045β€” Not statedAvailable
NCH+44080β€” Not statedAvailable
NCH+46045β€” Not statedAvailable
NCH+46080β€” Not statedAvailable
NCH+52045β€” Not statedAvailable
NCH+52080β€” Not statedAvailable
NCH+53045β€” Not statedAvailable
NCH+53080β€” Not statedAvailable
NCH+54045β€” Not statedAvailable
NCH+54080β€” Not statedAvailable
NCH+56045β€” Not statedAvailable
NCH+56080β€” Not statedAvailable
NCH+62045β€” Not statedAvailable
NCH+62080β€” Not statedAvailable
NCH+63045β€” Not statedAvailable
NCH+63080β€” Not statedAvailable
NCH+64045β€” Not statedAvailable
NCH+64080β€” Not statedAvailable
NCH+66045β€” Not statedAvailable
NCH+66080β€” Not statedAvailable
NCH+72045β€” Not statedAvailable
NCH+72080β€” Not statedAvailable
NCH+73045β€” Not statedAvailable
NCH+73080β€” Not statedAvailable
NCH+74045β€” Not statedAvailable
NCH+74080β€” Not statedAvailable
NCH+76045β€” Not statedAvailable
NCH+76080β€” Not statedAvailable
NCH+82045β€” Not statedAvailable
NCH+82080β€” Not statedAvailable
NCH+83045β€” Not statedAvailable
NCH+83080β€” Not statedAvailable
NCH+84045β€” Not statedAvailable
NCH+84080β€” Not statedAvailable
NCH+86045β€” Not statedAvailable
NCH+86080β€” Not statedAvailable
NCH+92045β€” Not statedAvailable
NCH+92080β€” Not statedAvailable
NCH+93045β€” Not statedAvailable
NCH+93080β€” Not statedAvailable
NCH+94045β€” Not statedAvailable
NCH+94080β€” Not statedAvailable
NCH+96045β€” Not statedAvailable
NCH+96080β€” Not statedAvailable
NCH+102045β€” Not statedAvailable
NCH+102080β€” Not statedAvailable
NCH+103045β€” Not statedAvailable
NCH+103080β€” Not statedAvailable
NCH+104045β€” Not statedAvailable
NCH+104080β€” Not statedAvailable
NCH+106045β€” Not statedAvailable
NCH+106080β€” Not statedAvailable

FDA clearances

  • 510(k) K151141 January 2016

Procedures that use angioplasty balloons

Frequently asked questions

What is Cronus HP - OTW PTA BALLOON 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 Cronus HP - OTW PTA BALLOON CATHETER?

Cronus HP - OTW PTA BALLOON CATHETER is made by Nipro Medical Corporation. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Cronus HP - OTW PTA BALLOON CATHETER come in?

The FDA device database does not list sizes for Cronus HP - OTW PTA BALLOON CATHETER. Check the instructions for use or ask a Nipro Medical Corporation representative.

Is Cronus HP - OTW PTA BALLOON CATHETER MRI safe?

The FDA device database entry for Cronus HP - OTW PTA BALLOON CATHETER does not state its MRI safety status. Check the labeling before MRI.

Is Cronus HP - OTW PTA BALLOON CATHETER FDA cleared?

Cronus HP - OTW PTA BALLOON CATHETER is covered by FDA submission K151141.

How do I contact a Nipro Medical Corporation sales representative?

Nipro Medical Corporation has not listed representatives on LA Vascular yet. Visit the Nipro Medical Corporation 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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