BOVINE PERICARDIUM PATCH— 510(k) K141721

Name: FDA 510(k) clearance K141721
Creator: U.S. Food and Drug Administration
Published: 2014-12-22

Substantially Equivalent

Collafirm, LLC

FDA 510(k) clearance K141721 for BOVINE PERICARDIUM PATCH, Substantially Equivalent on 2014-12-22. Applicant: Collafirm, LLC. Device class: 2.

Clearance details

Applicant: Collafirm, LLC
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2014-06-25
Decision date: 2014-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Jct, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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