DWD · Class II · 21 CFR 870.4430

FDA Product Code DWD: Suction Control, Intracardiac, Cardiopulmonary Bypass

Leading manufacturers include American Omni Medical, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Gish Biomedical, Inc..

15
Total
15
Cleared
106d
Avg days
1976
Since

FDA 510(k) Cleared Suction Control, Intracardiac, Cardiopulmonary Bypass Devices (Product Code DWD)

15 devices
1–15 of 15
Cleared Feb 18, 2000
IBC VRV, MODEL 1350
K992657
International Biophysics Corp.
Cardiovascular · 193d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.
K915480
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 32d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
K915481
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 32d
Cleared Jan 07, 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 32d
Cleared Jan 19, 1990
MEDISEAL SUCTION CANISTER
K895427
Deroyal Industries, Inc.
Cardiovascular · 136d
Cleared Jan 06, 1987
MODIFIED RLV-2100 B
K864503
American Omni Medical, Inc.
Cardiovascular · 53d
Cleared Nov 18, 1986
SARNS SAFETY LOOP
K863593
3M Health Care, Sarns
Cardiovascular · 64d
Cleared Aug 29, 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540
Gish Biomedical, Inc.
Cardiovascular · 58d
Cleared Jun 26, 1986
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
K861428
American Omni Medical, Inc.
Cardiovascular · 71d
Cleared Aug 05, 1985
AJDJUSTABLE SUCTION CONTROL VALVE
K851406
American Omni Medical, Inc.
Cardiovascular · 118d
Cleared Feb 28, 1983
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
K830149
Instrumentation Laboratory CO
Chemistry · 42d
Cleared Feb 28, 1983
VEINPREP VEIN GRAFT PREP. KIT A277723
K830150
Atrium Medical Corp.
Cardiovascular · 42d
Cleared Dec 09, 1976
VACUUM RELIEF VALVE
K760894
Delta Medical Industries
Cardiovascular · 44d

About Product Code DWD - Regulatory Context