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
49–72 of 137
Cleared May 31, 1995
SCIMED GATEWAY PLUS
K951089
Scimed Life Systems, Inc.
Cardiovascular · 83d
Cleared Mar 03, 1995
RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE
K945931
Research Industries Corp.
Cardiovascular · 88d
Cleared Feb 03, 1995
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
K945461
Medtronics Interventional Vascular
Cardiovascular · 88d
Cleared Jul 05, 1994
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
K911884
Advance Medical Designs, Inc.
Cardiovascular · 1163d
Cleared Mar 23, 1994
CHECK VALVE (FITTING)
K933084
Merit Medical Systems, Inc.
Cardiovascular · 273d
Cleared Nov 23, 1993
STOPCOCK (ONE-PORT MANIFOLD)
K934123
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared May 17, 1993
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
K922840
Gish Biomedical, Inc.
Cardiovascular · 339d
Cleared Jan 22, 1993
PASSAGE HEMOSTASIS VALVE
K925419
Merit Medical Systems, Inc.
Cardiovascular · 87d
Cleared Dec 11, 1992
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
K915301
Advance Medical Designs, Inc.
Cardiovascular · 386d
Cleared May 20, 1992
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared Dec 20, 1991
CUSTOM TUBING PACKS
K913363
Kroy Medical, Inc.
Cardiovascular · 144d
Cleared Nov 05, 1991
TORQUE FITTING
K912969
Freedom Machine, Inc.
Cardiovascular · 120d
Cleared Oct 21, 1991
MERIT MANIFOLD
K913161
Merit Medical Systems, Inc.
Cardiovascular · 96d
Cleared Sep 11, 1991
MX 339 TWIN HEMOSTATIC Y CONNECTOR
K912709
Medex, Inc.
Cardiovascular · 84d
Cleared May 21, 1991
ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012
K910845
Interventional Therapeutics Corp.
Cardiovascular · 83d
Cleared Nov 01, 1990
VASCUMED EZ Y-CONNECTOR
K902741
Vascumed Systems
Cardiovascular · 132d
Cleared Aug 15, 1990
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
K900994
Dlp, Inc.
Cardiovascular · 166d
Cleared Jun 26, 1990
NAMIC PTCA Y-ADAPTOR
K900652
North American Instrument Corp.
Cardiovascular · 137d
Cleared Mar 27, 1990
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
K897137
Research Medical, Inc.
Cardiovascular · 90d
Cleared Mar 27, 1990
ADVANCE STOPCOCKS ADVANCE MANIFOLDS
K897196
Advance Medical Designs, Inc.
Cardiovascular · 88d
Cleared Mar 19, 1990
ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.
K897197
Advance Medical Designs, Inc.
Cardiovascular · 80d
Cleared Jan 26, 1990
HPD TUBING CONNECTORS
K895795
Hpd Medical, Inc.
Cardiovascular · 121d
Cleared Dec 07, 1989
RMI CARDIOPLEGIA DELIVERY SETS
K892368
Research Medical, Inc.
Cardiovascular · 245d
Cleared Dec 07, 1989
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
K892377
Research Medical, Inc.
Cardiovascular · 245d