Angioplasty balloons

PowerCross

by Covidien LP

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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PowerCross models and sizes

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

Model / catalog no.SizeMRIStatus
AB18W020020090Catheter Gauge 4 Fr; Length 20 mm; Outer Diameter 2 mm Not statedAvailable
AB18W020020150Outer Diameter 2 mm; Length 20 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W020040090Catheter Gauge 4 Fr; Length 40 mm; Outer Diameter 2 mm Not statedAvailable
AB18W020040150Length 40 mm; Outer Diameter 2 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W020100090Length 100 mm; Outer Diameter 2 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W020100150Length 100 mm; Outer Diameter 2 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W020150090Catheter Gauge 4 Fr; Length 150 mm; Outer Diameter 2 mm Not statedAvailable
AB18W020150150Length 150 mm; Outer Diameter 2 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W020200090Catheter Gauge 4 Fr; Outer Diameter 2 mm; Length 200 mm Not statedAvailable
AB18W020200150Outer Diameter 2 mm; Length 200 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W025020090Catheter Gauge 4 Fr; Length 20 mm; Outer Diameter 2.5 mm Not statedAvailable
AB18W025020150Length 20 mm; Outer Diameter 2.5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W025040090Catheter Gauge 4 Fr; Outer Diameter 2.5 mm; Length 40 mm Not statedAvailable
AB18W025040150Outer Diameter 2.5 mm; Length 40 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W025100090Length 100 mm; Outer Diameter 2.5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W025100150Length 100 mm; Outer Diameter 2.5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W025150090Catheter Gauge 4 Fr; Outer Diameter 2.5 mm; Length 150 mm Not statedAvailable
AB18W025150150Length 150 mm; Outer Diameter 0.5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W025200090Length 200 mm; Outer Diameter 2.5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W025200150Length 200 mm; Outer Diameter 2.5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030020090Outer Diameter 3 mm; Length 20 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030020150Catheter Gauge 4 Fr; Length 20 mm; Outer Diameter 3 mm Not statedAvailable
AB18W030040090Length 40 mm; Outer Diameter 3 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030040150Outer Diameter 3 mm; Length 40 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030060090Catheter Gauge 4 Fr; Outer Diameter 3 mm; Length 60 mm Not statedAvailable
AB18W030060150Outer Diameter 3 mm; Length 60 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030080090Outer Diameter 3 mm; Length 80 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030080150Outer Diameter 3 mm; Length 80 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030100090Outer Diameter 3 mm; Length 100 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030100150Outer Diameter 3 mm; Length 100 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030120090Length 120 mm; Outer Diameter 3 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030120150Length 120 mm; Outer Diameter 3 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030150090Length 150 mm; Outer Diameter 3 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030150150Length 150 mm; Outer Diameter 3 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030200090Length 200 mm; Outer Diameter 3 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W030200150Outer Diameter 3 mm; Length 200 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040020090Outer Diameter 4 mm; Length 20 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040020150Length 20 mm; Outer Diameter 4 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040040090Outer Diameter 4 mm; Length 40 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040040150Length 40 mm; Outer Diameter 4 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040060090Outer Diameter 4 mm; Length 60 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040060150Outer Diameter 4 mm; Length 60 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040080090Length 80 mm; Outer Diameter 4 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040080150Outer Diameter 4 mm; Length 80 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040100090Outer Diameter 4 mm; Length 100 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040100150Length 100 mm; Outer Diameter 4 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040120090Length 120 mm; Outer Diameter 4 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040120150Length 120 mm; Outer Diameter 4 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040150090Length 150 mm; Outer Diameter 4 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040150150Outer Diameter 4 mm; Length 150 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040200090Outer Diameter 4 mm; Length 200 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W040200150Catheter Gauge 4 Fr; Length 200 mm; Outer Diameter 4 mm Not statedAvailable
AB18W050020090Length 20 mm; Outer Diameter 5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W050020150Length 20 mm; Outer Diameter 5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W050040090Outer Diameter 5 mm; Length 40 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W050040150Length 40 mm; Outer Diameter 5 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W050060090Length 60 mm; Outer Diameter 5 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050060150Length 60 mm; Outer Diameter 5 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050080090Catheter Gauge 5 Fr; Outer Diameter 5 mm; Length 80 mm Not statedAvailable
AB18W050080150Outer Diameter 5 mm; Length 80 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050100090Catheter Gauge 5 Fr; Outer Diameter 5 mm; Length 100 mm Not statedAvailable
AB18W050100150Catheter Gauge 5 Fr; Length 100 mm; Outer Diameter 5 mm Not statedAvailable
AB18W050120090Outer Diameter 5 mm; Length 120 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050120150Length 120 mm; Outer Diameter 5 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050150090Outer Diameter 5 mm; Length 150 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050150150Outer Diameter 5 mm; Length 150 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050200090Length 200 mm; Outer Diameter 5 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W050200150Length 200 mm; Outer Diameter 5 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060020090Length 90 cm Not statedAvailable
AB18W060020150Length 20 mm; Outer Diameter 6 mm; Catheter Gauge 4 Fr Not statedAvailable
AB18W060040090Length 40 mm; Outer Diameter 6 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060040150Length 40 mm; Outer Diameter 6 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060060090Catheter Gauge 5 Fr; Length 60 mm; Outer Diameter 6 mm Not statedAvailable
AB18W060060150Outer Diameter 6 mm; Length 60 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060080090Outer Diameter 6 mm; Length 80 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060080150Outer Diameter 6 mm; Length 80 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060100090Length 100 mm; Outer Diameter 6 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060100150Length 100 mm; Outer Diameter 6 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060120090Catheter Gauge 5 Fr; Length 120 mm; Outer Diameter 6 mm Not statedAvailable
AB18W060120150Length 120 mm; Outer Diameter 6 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060150090Outer Diameter 6 mm; Length 150 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060150150Outer Diameter 6 mm; Length 150 mm; Catheter Gauge 5 Fr Not statedAvailable
AB18W060200090Length 200 mm; Outer Diameter 6 mm; Catheter Gauge 6 Fr Not statedAvailable
AB18W060200150Outer Diameter 6 mm; Length 200 mm; Catheter Gauge 6 Fr Not statedAvailable

FDA clearances

  • 510(k) K093286 November 2009

Procedures that use angioplasty balloons

Frequently asked questions

What is PowerCross 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 PowerCross?

PowerCross is made by Covidien LP. It is listed under peripheral angioplasty balloons in our device library.

What sizes does PowerCross come in?

Sizes listed for PowerCross: Outer Diameter: 0.5–6 mm; Length: 20–200 mm; Catheter Gauge: 4–6 Fr. Confirm availability with the manufacturer's instructions for use.

Is PowerCross MRI safe?

The FDA device database entry for PowerCross does not state its MRI safety status. Check the labeling before MRI.

Is PowerCross FDA cleared?

PowerCross is covered by FDA submission K093286.

How do I contact a Covidien LP sales representative?

Covidien LP has not listed representatives on LA Vascular yet. Visit the Covidien LP 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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