510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K051405Substantially Equivalent

Regensis Pericardial Patch

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

K051405 is the FDA 510(k) clearance record for REGENSIS PERICARDIAL PATCH, a class II device, cleared for Cormatrix Cardiovascular, Inc. on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 7 510(k) clearances for Cormatrix Cardiovascular, Inc., from to . As of , FDA records show no recalls naming K051405.

Clearance record

Decision date
Received
(92 days to decision)
Product code
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Cormatrix Cardiovascular, Inc. 155 Moffett Park Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXZ

Trailing 12 months

FDA records hold no clearances under product code DXZ in the trailing twelve months.

FDA records show no clearances under product code DXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260