FDA 510(k) Applications for Medical Device Product Code "DWD"
(Suction Control, Intracardiac, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K863593 3M HEALTH CARE, SARNS SARNS SAFETY LOOP 11/18/1986
K851406 AMERICAN OMNI MEDICAL, INC. AJDJUSTABLE SUCTION CONTROL VALVE 08/05/1985
K864503 AMERICAN OMNI MEDICAL, INC. MODIFIED RLV-2100 "B" 01/06/1987
K861428 AMERICAN OMNI MEDICAL, INC. SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 06/26/1986
K830150 ATRIUM MEDICAL CORP. VEINPREP VEIN GRAFT PREP. KIT A277723 02/28/1983
K905311 BAXTER BENTLEY LABORATORIES, INC. DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. 01/15/1991
K915481 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT 01/07/1992
K915480 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. 01/07/1992
K915482 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT 01/07/1992
K760894 DELTA MEDICAL INDUSTRIES VACUUM RELIEF VALVE 12/09/1976
K895427 DEROYAL INDUSTRIES, INC. MEDISEAL SUCTION CANISTER 01/19/1990
K862540 GISH BIOMEDICAL, INC. LEFT VENTRICULAR VENT VALVE MODEL NO. GLV 08/29/1986
K830149 INSTRUMENTATION LABORATORY CO. IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- 02/28/1983
K992657 INTERNATIONAL BIOPHYSICS CORP. IBC VRV, MODEL 1350 02/18/2000
K920077 INTERNATIONAL MEDICAL PRODUCTS, INC. NIKKISO NK PUMP 09/29/1993


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