DTL · Class II · 21 CFR 870.4290

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

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

137
Total
137
Cleared
94d
Avg days
1976
Since
137 devices
73–96 of 137
Cleared Dec 11, 1985
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950
American Bentley
Cardiovascular · 77d
Cleared Dec 04, 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Nov 14, 1985
PRESSURE SENSING SYRINGE 65000
K853586
Dlp, Inc.
Cardiovascular · 80d
Cleared Aug 09, 1985
CAPIOX BLOOD SAMPLING MANIFOLD
K852086
Terumo Medical Corp.
Cardiovascular · 88d
Cleared Aug 05, 1985
SILENT GUARD CAT. NO. SG-30
K851465
American Omni Medical, Inc.
Cardiovascular · 116d
Cleared Dec 29, 1984
FILTER PURGE LINE EC-FPL SERIES
K833644
Gish Biomedical, Inc.
Cardiovascular · 439d
Cleared Oct 18, 1984
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
K842829
North American Instrument Corp.
Cardiovascular · 90d
Cleared Apr 24, 1984
MALE-MALE LUER LOCK CONNECTOR W/ROTA
K840797
American Pharmaseal Div. Ahsc
Cardiovascular · 61d
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 Nov 27, 1981
VYGON STOPCOCKS & RAMPS(MANIFOLDS)
K813141
Exco, Inc.
Cardiovascular · 22d
Cleared Jan 16, 1981
DISPOSABLE QUICK RELEASE PERFUSION ADAP
K802544
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Aug 27, 1980
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828
Graphic Controls Corp.
Cardiovascular · 27d
Cleared Jun 30, 1980
CORONARY PERFUSION CONNECTOR PLUG
K801399
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
QUICKIE PRIME CARDIOP. BYPASS PERF. INTR
K801402
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PARALLEL Y CONNECTORS
K801404
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PERFUSION CONNECTORS
K801405
Texas Medical Products, Inc.
Cardiovascular · 17d
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