# K052149: Edwards Peripheral Dilation Catheter

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 2, 2005 after 25 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 3 generations back to K993720 (2000). 8 ancestors in all.
47 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032587: Edwards Peripheral Dilatation Catheter, Edwards Lifesciences, LLC (2003) Summary page 1.
- K050627: Lifestent Turbo Biliary Stent Systems, Edwards Lifesciences, LLC (2005) Summary page 1.

## Most influential descendants
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 29 descendants of its own
- K122685: Angiosculpt Pta Scoring Balloon Catheter (2013), 28 descendants of its own
- K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting (2014), 24 descendants of its own

## Indications for use
The Edwards Peripheral Dilation Catheter is intended to: * dilate stenoses in peripheral arteries, * treat obstructive lesions of native or synthetic A-V fistulae and/or * re-expand endoluminal stent graft elements in the aorta and iliac arteries

Source page: https://510kreport.com/device/K052149
Methodology: https://510kreport.com/methodology