# K112797: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: May 4, 2012 after 221 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001134 (2000). 16 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032737: Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon Catheter, Cordis Powerflex P3 Pta, Cordis Europa, N.V. (2003) Summary page 1.
- K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter, Cordis Europa, N.V. (2007) Summary page 3.
- K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters, ClearStream Technologies, Ltd. (2008) Summary page 1.

## Most influential descendants
- K121442: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter (2012), 9 descendants of its own
- K133843: Saber Percutaneous Transluminal Angioplasty Dilatation Catheter (2014), 6 descendants of its own
- K151153: Pirouette 018 (2015), 4 descendants of its own
- K162316: Pirouette 014 (2016), 2 descendants of its own
- K161427: Pirouette 035 (2016), 2 descendants of its own

## Indications for use
The PowerflexM Pro PTA catheter is intended to dilate stenoses in iliac, femoral, ilia-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K112797
Methodology: https://510kreport.com/methodology