# K162506: PhotoFix Decellularized Bovine Pericardium

- Pathway: 510(k) (Traditional)
- Applicant: Cryolife, Inc.
- Decided: Mar 9, 2017 after 182 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- 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: 1 generation back to K993288 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993288: Sulzer Carbomedics Cardiofix Pericardium, Sulzer Carbomedics, Inc. (1999) Summary page 4.

## Indications for use
PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.

Source page: https://510kreport.com/device/K162506
Methodology: https://510kreport.com/methodology