K162506 is an FDA 510(k) clearance for the PhotoFix Decellularized Bovine Pericardium. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ).
Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on March 9, 2017, 182 days after receiving the submission on September 8, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K162506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2016 |
| Decision Date | March 09, 2017 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3470 |