Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
FDA product code DTL · 134 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.4290
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-11-12 – 2013-08-28
DTL
2013-08-28
DTL
2012-12-13
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
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DTL
2012-10-12
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
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DTL
2012-09-07
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
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DTL
2012-04-03
MEDLINE STOPCOCK AND MANIFOLD
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DTL
2012-02-28
E-PASS
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DTL
2012-01-25
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
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DTL
2012-01-20
DISPOSABLE HEMOSTATIC Y-CONNECTORS
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DTL
2012-01-12
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
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DTL
2010-05-21
GUARDIAN II NC HEMOSTASIS VALVE
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DTL
2010-05-19
TERUMO LAUER LOCK ADAPTER
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DTL
2010-04-28
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L
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DTL
2010-03-01
NMI FC
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DTL
2009-11-04
GATOR CLIPSEAL PLUG
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DTL
2009-10-01
GUARDIAN II HEMOSTASIS VALVE
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DTL
2008-04-23
SEDAT MYSHELL LITE
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DTL
2008-03-13
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
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DTL
2008-03-05
CAPIOX CIRCUIT CONNECTORS
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DTL
2008-02-27
GUARDIAN HEMOSTASIS VALVE
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DTL
2008-01-04
Y-GLIDE
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DTL
2007-11-20
HEMOSTASIS VALVE
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DTL
2006-06-29
Y-CLICK CONNECTOR
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DTL
2006-01-11
6248VAL ADJUSTABLE VALVE
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DTL
2005-11-21
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
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DTL
2004-10-06
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
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DTL
2004-08-11
TERUMO CIRCUIT CONNECTORS
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DTL
2004-07-02
MYSHELL
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DTL
2004-01-16
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
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DTL
2003-07-02
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
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DTL
2003-05-20
IS-1 HEMOSTASIS VALVE, MODEL 6799
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DTL
2003-03-14
GISH TUBING AND CONNECTORS WITH GBS COATING
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DTL
2002-11-27
ADAPTERS WITH X-COATING
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DTL
2002-05-02
LV-1 HEMOSTASIS VALVE, MODEL #6789
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DTL
2001-02-07
ADAPTERS WITH X-COATING
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DTL
1999-11-10
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
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DTL
1999-10-05
MBA
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DTL
1999-06-09
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
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DTL
1997-10-08
MANIFOLD
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DTL
1996-12-17
HIGH PRESSURE INJECTION LINES
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DTL
1996-06-21
NMI VEIN GRAFT PERFUSION SET
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DTL
1996-03-04
HEMO-VALVE
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DTL
1996-02-12
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
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DTL
1996-02-02
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
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DTL
1995-08-24
QUEST VEIN GRAFT PERFUSION SET
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DTL
1995-06-21
BRAUN MANIFOLD
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DTL
1995-05-31
SCIMED GATEWAY PLUS
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DTL
1995-03-03
RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE
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DTL
1995-02-03
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
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DTL
1994-07-05
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
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DTL
1994-03-23
CHECK VALVE (FITTING)
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DTL
1993-11-23
STOPCOCK (ONE-PORT MANIFOLD)
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DTL
1993-05-17
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
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DTL
1993-01-22
PASSAGE HEMOSTASIS VALVE
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DTL
1992-12-11
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
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DTL
1992-05-20
HIGH PRESSURE CONNECTING SETS, MODIFICATION
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DTL
1991-12-20
CUSTOM TUBING PACKS
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DTL
1991-11-05
TORQUE FITTING
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DTL
1991-10-21
MERIT MANIFOLD
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DTL
1991-09-11
MX 339 TWIN HEMOSTATIC Y CONNECTOR
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DTL
1991-05-21
ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012
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DTL
1990-11-01
VASCUMED EZ Y-CONNECTOR
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DTL
1990-08-15
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
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DTL
1990-06-26
NAMIC PTCA Y-ADAPTOR
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DTL
1990-03-27
ADVANCE STOPCOCKS ADVANCE MANIFOLDS
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DTL
1990-03-27
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
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DTL
1990-03-19
ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.
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DTL
1990-01-26
HPD TUBING CONNECTORS
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DTL
1989-12-07
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
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DTL
1989-12-07
RMI CARDIOPLEGIA DELIVERY SETS
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DTL
1989-08-03
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
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DTL
1989-07-24
ANGIOGRAPHY CUSTOM PACKS
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DTL
1989-07-14
DISPOSABLE TRANSDUCER MANIFOLD
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DTL
1989-04-19
LIPID STOPCOCK
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DTL
1989-01-12
NAMIC DUAL BACKCHECK VALVE
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DTL
1988-12-28
PROCEDURE PACKS CONTRAST MEDIA SETS
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DTL
1988-12-05
USCI TANDEM ADAPTER
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DTL
1988-10-28
BIO-MEDICUS TUBING CONNECTORS
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DTL
1988-05-10
LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
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DTL
1988-01-19
ROTATING HEMOSTATIC VALVE
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DTL
1987-10-07
SILENT GUARD CAT. NO. SG-10
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DTL
1987-08-12
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
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DTL
1987-04-27
#014160-TAB TUBING ROTATOR ADAPTOR
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DTL
1987-02-20
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
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DTL
1986-10-31
LUER LOCK SKIRT
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DTL
1986-10-22
MEDI-PLAST DISPOSABLE MANIFOLD
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DTL
1986-10-15
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
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DTL
1986-09-29
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
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DTL
1986-07-17
DISPOSABLE STOPCOCK
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DTL
1986-03-31
TUBING CONNECTORS
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DTL
1986-02-10
DISPOSABLE MANIFOLD
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DTL
1986-01-13
CUSTOM CORONARY MANIFOLD KITS
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DTL
1986-01-08
HEMOSTATIC SIDEARM
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DTL
1985-12-11
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
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DTL
1985-12-04
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
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DTL
1985-12-03
L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION
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DTL
1985-11-14
PRESSURE SENSING SYRINGE 65000
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DTL
1985-08-09
CAPIOX BLOOD SAMPLING MANIFOLD
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DTL
1985-08-05
SILENT GUARD CAT. NO. SG-30
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DTL
1985-06-06
MANIFOLD CLAMPS
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DTL
1984-12-29
FILTER PURGE LINE EC-FPL SERIES
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