510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031785Substantially Equivalent

Macropore Cardio-Wrap (Ts)

Macropore Biosurgery, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031785 is the FDA 510(k) clearance record for MACROPORE CARDIO-WRAP (TS), a class II device, cleared for Macropore Biosurgery, Inc. on under FDA product code OMH (Pericardial Patch To Facilitate Revision Surgeries). FDA's definition for product code OMH reads: "Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation...". FDA records list 17 510(k) clearances for Macropore Biosurgery, Inc., from to . As of , FDA records show no recalls naming K031785.

Clearance record

Decision date
Received
(86 days to decision)
Product code
OMH Pericardial Patch To Facilitate Revision Surgeries
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Macropore Biosurgery, Inc. 6740 Top Gun St., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMH

Trailing 12 months

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

FDA records show no clearances under product code OMH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMH, 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