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
MALClass II

Graft, Vascular, Synthetic/Biologic Composite

21 CFR 870.3450 / Cardiovascular
FDA source (opens on fda.gov)

MAL is the FDA product code for Graft, Vascular, Synthetic/Biologic Composite, a class II device type, regulated under 21 CFR 870.3450. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 49 recalls.

Classification record

Product code
MAL
Device name
Graft, Vascular, Synthetic/Biologic Composite
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
49

Clearances, product code MAL

By decision year
6 clearances under product code MAL with a decision year between 1996 and 2012, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MAL by decision year
YearClearances
19961
20021
20051
20101
20111
20121

Applicants with the most clearances

Product code MAL
Applicants holding the most 510(k) clearances under product code MAL
ApplicantClearances
Boston Scientific Corporation2
LeMaitre Vascular Inc.2
Maquet Cardiovascular LLC1
Meadox Medicals, Div. Boston Scientific Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code