DTS · Class II · 21 CFR 870.4420

FDA Product Code DTS: Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Leading manufacturers include Gish Biomedical, Inc., California Medical Laboratories, Inc. and Estech, Inc..

9
Total
9
Cleared
91d
Avg days
1979
Since

FDA 510(k) Cleared Sucker, Cardiotomy Return, Cardiopulmonary Bypass Devices (Product Code DTS)

9 devices
1–9 of 9
Cleared Jan 26, 2006
ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
K053021
Estech, Inc.
Cardiovascular · 92d
Cleared Sep 30, 1998
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
K982891
California Medical Laboratories, Inc.
Cardiovascular · 44d
Cleared Nov 14, 1997
IBC CARDIAC SUCTION WARD
K963756
International Biophysics Corp.
Cardiovascular · 423d
Cleared Jan 23, 1991
FLEXIBLE INTRACARDIAC SUCTION DEVICE
K905008
Gish Biomedical, Inc.
Cardiovascular · 78d
Cleared Mar 28, 1990
HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES
K900339
Shiley, Inc.
Cardiovascular · 64d
Cleared Jun 13, 1989
ROBICSEK INTRACARDIAC SUCTION WAND
K891906
Gish Biomedical, Inc.
Cardiovascular · 78d
Cleared Jul 28, 1980
OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT
K801641
Ohio Medical Products
Cardiovascular · 11d
Cleared Jun 30, 1980
DISPOSABLE SUCKER SYSTEM
K801400
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Oct 02, 1979
DISPOSSABLE SUCTION TUBE, 6 FRENCH
K791846
Dlp, Inc.
Cardiovascular · 13d

About Product Code DTS - Regulatory Context