ClearanceBrief
Panels › Cardiovascular › Product code DTS · Class 2

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Regulation 870.4420

0510(k)s in 12 months (9 all time)
0recalls in 12 months (11 all time)
8recalls that name a 510(k)
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Top companies in DTS

Company510(k)sRecalls
California Medical Laboratories, Inc.15
International Biophysics Corp.12
Terumo Cardiovascular Systems Corporation03
Gish Biomedical, Inc.20
Dlp, Inc.10
Estech, Inc.10
Medtronic Perfusion Systems01
Ohio Medical Products10
Shiley, Inc.10
Texas Medical Products, Inc.10
Decided510(k)Device and applicantCode
Jan 26, 2006K053021ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
Estech, Inc.
DTS
Sep 30, 1998K982891CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
California Medical Laboratories, Inc.
DTS
Nov 14, 1997K963756IBC CARDIAC SUCTION WARD
International Biophysics Corp.
DTS
Jan 23, 1991K905008FLEXIBLE INTRACARDIAC SUCTION DEVICE
Gish Biomedical, Inc.
DTS
Mar 28, 1990K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES
Shiley, Inc.
DTS
Jun 13, 1989K891906ROBICSEK INTRACARDIAC SUCTION WAND
Gish Biomedical, Inc.
DTS
Jul 28, 1980K801641OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT
Ohio Medical Products
DTS
Jun 30, 1980K801400DISPOSABLE SUCKER SYSTEM
Texas Medical Products, Inc.
DTS
Oct 2, 1979K791846DISPOSSABLE SUCTION TUBE, 6 FRENCH
Dlp, Inc.
DTS

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