510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K141721Substantially Equivalent

Bovine Pericardium Patch

Collafirm, LLC, Monmouth Jct NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141721 is the FDA 510(k) clearance record for BOVINE PERICARDIUM PATCH, a class II device, cleared for Collafirm, LLC on under FDA product code FTM (Mesh, Surgical). FDA records list 2 510(k) clearances for Collafirm, LLC, from to . As of , FDA records show no recalls naming K141721.

Clearance record

Decision date
Received
(180 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Collafirm, LLC 7 Deer Park Dr., Monmouth Jct NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTM

Trailing 12 months
1 clearance under product code FTM in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260