PhotoFix Decellularized Bovine Pericardium— 510(k) K172085

Name: FDA 510(k) clearance K172085
Creator: U.S. Food and Drug Administration
Published: 2017-12-04

Substantially Equivalent

Cryolife, Inc.

FDA 510(k) clearance K172085 for PhotoFix Decellularized Bovine Pericardium, Substantially Equivalent on 2017-12-04. Applicant: Cryolife, Inc.. Device class: 2.

Clearance details

Applicant: Cryolife, Inc.
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2017-07-11
Decision date: 2017-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

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