510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954848Substantially Equivalent - Subject to Tracking Reg.

Hemashield Microvel Velour Knitted Vascular Graft

Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K954848 is the FDA 510(k) clearance record for HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT, a class II device, cleared for Meadox Medicals, Div. Boston Scientific Corp. on under FDA product code MAL (Graft, Vascular, Synthetic/Biologic Composite). FDA records list 53 510(k) clearances for Meadox Medicals, Div. Boston Scientific Corp., from to . As of , FDA records show 6 recalls naming K954848.

Clearance record

Decision date
Received
(101 days to decision)
Product code
MAL Graft, Vascular, Synthetic/Biologic Composite
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Meadox Medicals, Div. Boston Scientific Corp. 112 Bauer Dr., Oakland NJ
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