510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K052302Substantially Equivalent

Hemashield Platinum Woven Double Velour Taaa Graft Configuration

Boston Scientific Corporation, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052302 is the FDA 510(k) clearance record for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION, a class II device, cleared for Boston Scientific Corp on under FDA product code MAL (Graft, Vascular, Synthetic/Biologic Composite). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show 3 recalls naming K052302.

Clearance record

Decision date
Received
(19 days to decision)
Product code
MAL Graft, Vascular, Synthetic/Biologic Composite
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corp 2 Scimed Pl., Maple Grove MN
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