DTS · Class II · 21 CFR 870.4420

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

Leading manufacturers include Gish Biomedical, Inc., Dlp, Inc. and Texas Medical Products, 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 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