510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K021213Substantially Equivalent

Modification to Hemashield Platinum Woven/microvel Double Velour Vascular Grafts

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

K021213 is the FDA 510(k) clearance record for MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS, 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 20 recalls naming K021213.

Clearance record

Decision date
Received
(2 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 One Boston Scientific Pl., Natick, MA
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