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 Texas Medical Products, Inc..

137
Total
137
Cleared
94d
Avg days
1976
Since
137 devices
49–72 of 137
Cleared May 20, 1992
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987
E-Z-Em, Inc.
Cardiovascular · 209d
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 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 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
Cleared Aug 03, 1989
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683
3M Company
Cardiovascular · 79d
Cleared Apr 19, 1989
LIPID STOPCOCK
K890580
North American Instrument Corp.
Cardiovascular · 72d
Cleared Jan 12, 1989
NAMIC DUAL BACKCHECK VALVE
K884408
North American Instrument Corp.
Cardiovascular · 85d
Cleared Dec 05, 1988
USCI TANDEM ADAPTER
K884200
C.R. Bard, Inc.
Cardiovascular · 60d
Cleared Jan 19, 1988
ROTATING HEMOSTATIC VALVE
K873971
Target Therapeutics
Cardiovascular · 112d
Cleared Oct 07, 1987
SILENT GUARD CAT. NO. SG-10
K873488
American Omni Medical, Inc.
Cardiovascular · 37d
Cleared Aug 12, 1987
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161
Shiley, Inc.
Cardiovascular · 69d
Cleared Oct 31, 1986
LUER LOCK SKIRT
K862451
Hewlett-Packard Co.
Cardiovascular · 126d
Cleared Oct 15, 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177
Cordis Corp.
Cardiovascular · 58d
Cleared Sep 29, 1986
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
K863661
Medical Components, Inc.
Cardiovascular · 11d
Cleared Jul 17, 1986
DISPOSABLE STOPCOCK
K861783
Utah Medical Products, Inc.
Cardiovascular · 70d
Cleared Feb 10, 1986
DISPOSABLE MANIFOLD
K854960
Utah Medical Products, Inc.
Cardiovascular · 61d
Cleared Jan 08, 1986
HEMOSTATIC SIDEARM
K854397
Target Therapeutics
Cardiovascular · 69d