MAL · Class II · 21 CFR 870.3450

FDA Product Code MAL: Graft, Vascular, Synthetic/biologic Composite

Leading manufacturers include Boston Scientific Corp, LeMaitre Vascular, Inc. and Maquet Cardiovascular, LLC.

6
Total
6
Cleared
53d
Avg days
1996
Since

FDA 510(k) Cleared Graft, Vascular, Synthetic/biologic Composite Devices (Product Code MAL)

6 devices
1–6 of 6
Cleared Sep 10, 2012
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX
K122612
Maquet Cardiovascular, LLC
Cardiovascular · 14d
Cleared Jan 19, 2011
ALBOGRAFT VASCULAR PROSTHESIS
K103080
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Jan 14, 2010
ALBOGRAFT VASCULAR PROSTHESIS
K093231
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Sep 12, 2005
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
K052302
Boston Scientific Corp
Cardiovascular · 19d
Cleared Apr 19, 2002
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213
Boston Scientific Corp
Cardiovascular · 2d
Cleared Feb 01, 1996
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
K954848
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 101d

About Product Code MAL - Regulatory Context