# K172660: Duravess bovine pericardial vascular patch

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 17, 2017 after 73 days
- Product code: PSQ (Intracardiac Patch Or Pledget, Biologically Derived)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K842066 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082139: Edwards Bovine Pericardial Patch, Model 4700, Edwards Lifesciences, LLC (2008) Summary page 4.

## Indications for use
The bovine pericardial vascular patch is intended for use as a surgical patch material for: vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; and suture-line buttressing.

Source page: https://510kreport.com/device/K172660
Methodology: https://510kreport.com/methodology