# K183635: PhotoFix Decellularized Bovine Pericardium

- Pathway: 510(k) (Special)
- Applicant: Cryolife, Inc.
- Decided: Feb 14, 2019 after 50 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: 1 generation back to K172085 (2017). 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)
- K172085: PhotoFix Decellularized Bovine Pericardium, Cryolife, Inc. (2017) Summary page 4.

## Indications for use
PhotoFix is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

Source page: https://510kreport.com/device/K183635
Methodology: https://510kreport.com/methodology