The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Photofix Decellularized Bovine Pericardium.
| Device ID | K183635 |
| 510k Number | K183635 |
| Device Name: | PhotoFix Decellularized Bovine Pericardium |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | CryoLife, Inc. 1655 Roberts Blvd. NW Kennesaw, GA 30144 |
| Contact | Heather Emerick |
| Correspondent | Heather Emerick CryoLife, Inc. 1655 Roberts Blvd. NW Kennesaw, GA 30144 |
| Product Code | PSQ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-02-14 |
| Summary: | summary |