PhotoFix Decellularized Bovine Pericardium
K-Number: K162506 · 2017-03-09
ApplicantCryolife, Inc.
Decision Date2017-03-09
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PhotoFix Decellularized Bovine Pericardium is a medical device manufactured by Cryolife, Inc.. It received FDA 510(k) clearance on 2017-03-09 under approval number K162506. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PhotoFix Decellularized Bovine Pericardium?
PhotoFix Decellularized Bovine Pericardium is a medical device that received FDA 510(k) clearance on 2017-03-09. It is manufactured by Cryolife, Inc.. The 510(k) number is K162506.
When was PhotoFix Decellularized Bovine Pericardium approved by the FDA?
PhotoFix Decellularized Bovine Pericardium received FDA 510(k) clearance on 2017-03-09, under approval number K162506.
What company makes PhotoFix Decellularized Bovine Pericardium?
PhotoFix Decellularized Bovine Pericardium is manufactured by Cryolife, Inc..
What is the FDA product code for PhotoFix Decellularized Bovine Pericardium?
The FDA product code for PhotoFix Decellularized Bovine Pericardium is DXZ.
Other Devices by Cryolife, Inc.
Related Devices (Code: DXZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.