KPK · Class II · 21 CFR 878.4650

FDA Product Code KPK: Marker, Ostia, Aorto-saphenous Vein

Leading manufacturers include C.R. Bard, Inc., Cook, Inc. and Scanlan Intl., Inc..

6
Total
6
Cleared
69d
Avg days
1977
Since

FDA 510(k) Cleared Marker, Ostia, Aorto-saphenous Vein Devices (Product Code KPK)

6 devices
1–6 of 6
Cleared Jan 26, 1998
CORONARY VEIN GRAFT TAG MARKER
K971966
Med-Edge, Inc.
Cardiovascular · 243d
Cleared Jan 12, 1987
SCANLAN (TM) VEIN/GRAFT HOLDER
K864919
Scanlan Intl., Inc.
Cardiovascular · 27d
Cleared Oct 30, 1986
COOK (R) VEIN GRAFT RING MARKERS
K864101
Cook, Inc.
Cardiovascular · 9d
Cleared Aug 27, 1980
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.
K801637
C.R. Bard, Inc.
Cardiovascular · 41d

About Product Code KPK - Regulatory Context