510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140306Substantially Equivalent

Cormatrix Protect Ecm Envelope

Cormatrix Cardiovascular, Inc., Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140306 is the FDA 510(k) clearance record for CORMATRIX PROTECT ECM ENVELOPE, a class II device, cleared for Cormatrix Cardiovascular, Inc. on under FDA product code FTM (Mesh, Surgical). FDA records list 7 510(k) clearances for Cormatrix Cardiovascular, Inc., from to . As of , FDA records show 2 recalls naming K140306.

Clearance record

Decision date
Received
(189 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cormatrix Cardiovascular, Inc. 1100 Old Ellis Rd., Roswell GA
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