# K121442: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corporation
- Decided: Jun 14, 2012 after 30 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001134 (2000). 17 ancestors in all.
9 later devices descend from it; 2 cite 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)
- K112797: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter, Cordis Corp. (2012) Summary page 1.

## Most influential descendants
- 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
- K201333: SABER .035 PTA Dilatation Catheter (2020), 1 descendant of its own

## Recalls of this device
- Sep 5, 2018 · Class II · Z-0390-2019: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
- Dec 22, 2014 · Class II · Z-0998-2015: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.

## Indications for use
The Powerflex Tm Pro PTA catheter is intended to dilate stenoses in iliac, femoral, illo-fmoral, popliteal, infra popliteal and renal arter/es and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysisjis tubae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculoture.

Source page: https://510kreport.com/device/K121442
Methodology: https://510kreport.com/methodology