PhotoFix Decellularized Bovine Pericardium— 510(k) K183635

Name: FDA 510(k) clearance K183635
Creator: U.S. Food and Drug Administration
Published: 2019-02-14

Substantially Equivalent

Cryolife, Inc.

FDA 510(k) clearance K183635 for PhotoFix Decellularized Bovine Pericardium, Substantially Equivalent on 2019-02-14. 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: 2018-12-26
Decision date: 2019-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cryolife, Inc.

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K110581 — PROPATCH SOFT TISSUE REPAIR MATRIX2012-01-10
K101587 — PROPATCH SOFT TISSUE REPAIR MATRIX2010-09-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.