MAL · Class II · 21 CFR 870.3450

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

Leading manufacturers include Boston Scientific Corp.

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 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

About Product Code MAL - Regulatory Context