510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122612Substantially Equivalent

Hemashield Woven Double Velour Vascular Graft Model M00202175xxxxx; M00202166xxxxx

Maquet Cardiovascular LLC, Wayne NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122612 is the FDA 510(k) clearance record for HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX, a class II device, cleared for Maquet Cardiovascular, LLC on under FDA product code MAL (Graft, Vascular, Synthetic/Biologic Composite). FDA records list 14 510(k) clearances for Maquet Cardiovascular, LLC, from to . As of , FDA records show no recalls naming K122612.

Clearance record

Decision date
Received
(14 days to decision)
Product code
MAL Graft, Vascular, Synthetic/Biologic Composite
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Maquet Cardiovascular, LLC 45 Barbour Pond Dr., Wayne NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAL

Trailing 12 months

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

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