DTL · Class II · 21 CFR 870.4290

FDA Product Code DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Leading manufacturers include Merit Medical Systems, Inc., Dlp, Inc. and Gish Biomedical, Inc..

137
Total
137
Cleared
94d
Avg days
1976
Since
137 devices
49–72 of 137
Cleared Apr 19, 1984
ARTERIAL FILTER PURGE LINE W/CHECK VALV
K840603
Shiley, Inc.
Cardiovascular · 69d
Cleared Dec 16, 1983
TUBING CONNECTORS EC-2XXX SERIES
K833322
Gish Biomedical, Inc.
Cardiovascular · 81d
Cleared Jun 03, 1983
SCI MED TEMPERATURE MONITORING ADAPTOR
K831260
Scimed Life Systems, Inc.
Cardiovascular · 46d
Cleared Jun 03, 1983
SCI MED TUBING CONNECTORS
K831261
Scimed Life Systems, Inc.
Cardiovascular · 46d
Cleared Apr 15, 1982
NORTON MANIFOLD
K820864
Norton Performance Plastics Corp.
Cardiovascular · 17d
Cleared Mar 12, 1982
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297
C.R. Bard, Inc.
Cardiovascular · 36d
Cleared Aug 27, 1980
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Jun 04, 1980
SAMPLING MANIFOLD H530
K801200
C.R. Bard, Inc.
Cardiovascular · 16d
Cleared Dec 05, 1979
CONPHAR MANOMETER CONNECTORS
K792113
Conphar, Inc.
Cardiovascular · 41d
Cleared Oct 11, 1979
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914
Abbott Laboratories
Cardiovascular · 16d
Cleared Aug 28, 1979
ADAPTER-Y TYPE/CORONARY PERFUSION
K791498
Dlp, Inc.
Cardiovascular · 26d
Cleared Jun 22, 1979
STOPCOCK, THREE WAY
K791107
Norton Performance Plastics Corp.
Cardiovascular · 8d
Cleared May 25, 1979
PURGE LINE UNIT
K790804
Surgikos, Inc.
Cardiovascular · 31d
Cleared Apr 12, 1979
ADAPTERS-Y-TYPE
K790563
Dlp, Inc.
Cardiovascular · 24d
Cleared Apr 12, 1979
ADAPTER-STRAIGHT
K790564
Dlp, Inc.
Cardiovascular · 24d
Cleared Oct 05, 1978
MODIFIED STERILE DISPOSABLE STOPCOCKS
K781579
Cobe Laboratories, Inc.
Cardiovascular · 20d
Cleared Mar 02, 1978
COBE STOPCOCK
K780271
Cobe Laboratories, Inc.
Cardiovascular · 13d
Cleared Feb 01, 1978
OXYGENATOR HOLDER
K780056
C.R. Bard, Inc.
Cardiovascular · 22d