# K032587: Edwards Peripheral Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 2, 2003 after 41 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: 2 generations back to K993720 (2000). 3 ancestors in all.
48 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023907: Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon Dilation Catheter, Cordis Corp. (2002) Summary page 1.
- K023320: Agiltrac .035 Peripheral Dilatation Catheter, Guidant Corp. (2002) Summary page 1.

## Most influential descendants
- K052149: Edwards Peripheral Dilation Catheter (2005), 47 descendants of its own
- 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

## Indications for use
The Edwards Peripheral Dilatation Catheter is intended to: dilate stenoses in 10 - 14mm 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/K032587
Methodology: https://510kreport.com/methodology