FDA 510(k) Applications for Medical Device Product Code "DTS"
(Sucker, Cardiotomy Return, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K982891 CALIFORNIA MEDICAL LABORATORIES, INC. CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS 09/30/1998
K791846 DLP, INC. DISPOSSABLE SUCTION TUBE, 6 FRENCH 10/02/1979
K053021 ESTECH, INC. ESTECH CLEARVIEW MV ATRIAL DEPRESSOR 01/26/2006
K905008 GISH BIOMEDICAL, INC. FLEXIBLE INTRACARDIAC SUCTION DEVICE 01/23/1991
K891906 GISH BIOMEDICAL, INC. ROBICSEK INTRACARDIAC SUCTION WAND 06/13/1989
K963756 INTERNATIONAL BIOPHYSICS CORP. IBC CARDIAC SUCTION WARD 11/14/1997
K801641 OHIO MEDICAL PRODUCTS OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT 07/28/1980
K900339 SHILEY, INC. HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES 03/28/1990
K801400 TEXAS MEDICAL PRODUCTS, INC. DISPOSABLE SUCKER SYSTEM 06/30/1980


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