Duravess bovine pericardial vascular patch— 510(k) K172660

Name: FDA 510(k) clearance K172660
Creator: U.S. Food and Drug Administration
Published: 2017-11-17

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K172660 for Duravess bovine pericardial vascular patch, Substantially Equivalent on 2017-11-17. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2017-09-05
Decision date: 2017-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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