Angioplasty balloons
Powerflex
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 Powerflex
Contact Cordis US Corp. directly; they can quote, ship, or point you to the distributor for your country.
From cordis.com, checked October 2026.
No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.
Powerflex models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 4205020T | — | Not stated | Available |
| 4400302S | Length 2 cm | Not stated | Available |
| 4400304S | Length 4 cm | Not stated | Available |
| 4400304X | Length 4 cm | Not stated | Available |
| 4400306X | Length 6 cm | Not stated | Available |
| 4400308S | Length 8 cm | Not stated | Available |
| 4400308X | Length 8 cm | Not stated | Available |
| 4400310X | Length 10 cm | Not stated | Available |
| 4400312S | Length 12 cm | Not stated | Available |
| 4400315S | Length 15 cm | Not stated | Available |
| 4400315X | Length 15 cm | Not stated | Available |
| 4400322X | Length 22 cm | Not stated | Available |
| 4400402S | Length 2 cm | Not stated | Available |
| 4400402X | Length 2 cm | Not stated | Available |
| 4400406S | Length 6 cm | Not stated | Available |
| 4400408S | Length 8 cm | Not stated | Available |
| 4400408X | Length 8 cm | Not stated | Available |
| 4400412X | Length 12 cm | Not stated | Available |
| 4400415S | Length 15 cm | Not stated | Available |
| 4400415X | Length 15 cm | Not stated | Available |
| 4400422S | Length 22 cm | Not stated | Available |
| 4400422X | Length 22 cm | Not stated | Available |
| 4400502X | Length 2 cm | Not stated | Available |
| 4400503S | Length 3 cm | Not stated | Available |
| 4400503X | Length 3 cm | Not stated | Available |
| 4400504S | Length 4 cm | Not stated | Available |
| 4400504X | Length 4 cm | Not stated | Available |
| 4400506S | Length 6 cm | Not stated | Available |
| 4400506X | Length 6 cm | Not stated | Available |
| 4400508S | Length 8 cm | Not stated | Available |
| 4400510S | Length 10 cm | Not stated | Available |
| 4400510X | Length 10 cm | Not stated | Available |
| 4400512S | Length 12 cm | Not stated | Available |
| 4400512X | Length 12 cm | Not stated | Available |
| 4400515S | Length 15 cm | Not stated | Available |
| 4400522X | Length 22 cm | Not stated | Available |
| 4400602S | Length 2 cm | Not stated | Available |
| 4400603S | Length 3 cm | Not stated | Available |
| 4400603X | Length 3 cm | Not stated | Available |
| 4400604S | Length 4 cm | Not stated | Available |
| 4400604X | Length 4 cm | Not stated | Available |
| 4400606X | Length 6 cm | Not stated | Available |
| 4400608S | Length 8 cm | Not stated | Available |
| 4400608X | Length 8 cm | Not stated | Available |
| 4400610S | Length 10 cm | Not stated | Available |
| 4400610X | Length 10 cm | Not stated | Available |
| 4400615S | Length 15 cm | Not stated | Available |
| 4400622S | Length 22 cm | Not stated | Available |
| 4400622X | Length 22 cm | Not stated | Available |
| 4400702S | Length 2 cm | Not stated | Available |
| 4400703X | Length 3 cm | Not stated | Available |
| 4400704S | Length 4 cm | Not stated | Available |
| 4400704X | Length 4 cm | Not stated | Available |
| 4400706S | Length 6 cm | Not stated | Available |
| 4400706X | Length 6 cm | Not stated | Available |
| 4400708S | Length 8 cm | Not stated | Available |
| 4400802S | Length 2 cm | Not stated | Available |
| 4400802X | Length 2 cm | Not stated | Available |
| 4400803S | Length 3 cm | Not stated | Available |
| 4400803X | Length 3 cm | Not stated | Available |
| 4400804X | Length 4 cm | Not stated | Available |
| 4400806S | Length 6 cm | Not stated | Available |
| 4400806X | Length 6 cm | Not stated | Available |
| 4400808S | Length 8 cm | Not stated | Available |
| 4400810S | Length 10 cm | Not stated | Available |
| 4400810X | Length 10 cm | Not stated | Available |
| 4400902S | Length 2 cm | Not stated | Available |
| 4400903S | Length 3 cm | Not stated | Available |
| 4400903X | Length 3 cm | Not stated | Available |
| 4400904S | Length 4 cm | Not stated | Available |
| 4400906S | Length 6 cm | Not stated | Available |
| 4400908S | Length 8 cm | Not stated | Available |
| 4400908X | Length 8 cm | Not stated | Available |
| 4400910X | Length 10 cm | Not stated | Available |
| 4401002S | Length 2 cm | Not stated | Available |
| 4401002X | Length 2 cm | Not stated | Available |
| 4401003X | Length 3 cm | Not stated | Available |
| 4401004S | Length 4 cm | Not stated | Available |
| 4401006S | Length 6 cm | Not stated | Available |
| 4401006X | Length 6 cm | Not stated | Available |
| 4401008S | Length 8 cm | Not stated | Available |
| 4401008X | Length 8 cm | Not stated | Available |
| 4401010S | Length 10 cm | Not stated | Available |
| 4401010X | Length 10 cm | Not stated | Available |
| 4401202S | Length 2 cm | Not stated | Available |
| 4401203S | Length 3 cm | Not stated | Available |
| 4401203X | Length 3 cm | Not stated | Available |
| 4401204X | Length 4 cm | Not stated | Available |
| 4401206S | Length 6 cm | Not stated | Available |
| 4401206X | Length 6 cm | Not stated | Available |
FDA clearances
- 510(k) K112797 May 2012
- 510(k) K032737 October 2003
Procedures that use angioplasty balloons
Frequently asked questions
What is Powerflex 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 Powerflex?
Powerflex is made by Cordis US Corp.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Powerflex come in?
Sizes listed for Powerflex: Length: 2–22 cm. Confirm availability with the manufacturer's instructions for use.
Is Powerflex MRI safe?
The FDA device database entry for Powerflex does not state its MRI safety status. Check the labeling before MRI.
Is Powerflex FDA cleared?
Powerflex is covered by FDA submissions K112797, K032737.
How do I contact a Cordis US Corp. sales representative?
Cordis US Corp. has not listed representatives on LA Vascular yet. Visit the Cordis US Corp. 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.