DTL · Class II · 21 CFR 870.4290

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

Leading manufacturers include Merit Medical Systems, Inc., Texas Medical Products, Inc. and North American Instrument Corp..

137
Total
137
Cleared
94d
Avg days
1976
Since
137 devices
97–120 of 137
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