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
25–48 of 137
Cleared Jan 22, 1993
PASSAGE HEMOSTASIS VALVE
K925419
Merit Medical Systems, Inc.
Cardiovascular · 87d
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 Aug 15, 1990
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
K900994
Dlp, Inc.
Cardiovascular · 166d
Cleared Mar 27, 1990
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
K897137
Research Medical, Inc.
Cardiovascular · 90d
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 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 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
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 Dec 29, 1984
FILTER PURGE LINE EC-FPL SERIES
K833644
Gish Biomedical, Inc.
Cardiovascular · 439d
Cleared Apr 24, 1984
MALE-MALE LUER LOCK CONNECTOR W/ROTA
K840797
American Pharmaseal Div. Ahsc
Cardiovascular · 61d