Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- K170024Y-Connector Kit2Cleared 510(K)
- K152528Attachable Cath Lab Hemostasis Valve2Cleared 510(K)
- K143429Passage Hemostasis Valve2Cleared 510(K)
- K140475ROTATING ADAPTERS2Cleared 510(K)
- K131124COLIGN2Cleared 510(K)
- K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE2Cleared 510(K)
- K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE2Cleared 510(K)
- K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE2Cleared 510(K)
- K120069MEDLINE STOPCOCK AND MANIFOLD2Cleared 510(K)
- K113148E-PASS2Cleared 510(K)
- K113845TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE2Cleared 510(K)
- K113132DISPOSABLE HEMOSTATIC Y-CONNECTORS2Cleared 510(K)
- K113667CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING2Cleared 510(K)
- K101113GUARDIAN II NC HEMOSTASIS VALVE2Cleared 510(K)
- K093992TERUMO LAUER LOCK ADAPTER2Cleared 510(K)
- K100319MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L2Cleared 510(K)
- K091634NMI FC2Cleared 510(K)
- K092563GATOR CLIPSEAL PLUG2Cleared 510(K)
- K092711GUARDIAN II HEMOSTASIS VALVE2Cleared 510(K)
- K080472SEDAT MYSHELL LITE2Cleared 510(K)
- K073260LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-1092Cleared 510(K)
- K073474CAPIOX CIRCUIT CONNECTORS2Cleared 510(K)
- K073620GUARDIAN HEMOSTASIS VALVE2Cleared 510(K)
- K072745Y-GLIDE2Cleared 510(K)
- K072556HEMOSTASIS VALVE2Cleared 510(K)
- K060759Y-CLICK CONNECTOR2Cleared 510(K)
- K0524596248VAL ADJUSTABLE VALVE2Cleared 510(K)
- K052381GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER2Cleared 510(K)
- K042060EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE2Cleared 510(K)
- K041697TERUMO CIRCUIT CONNECTORS2Cleared 510(K)
- K040498MYSHELL2Cleared 510(K)
- K033328NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT2Cleared 510(K)
- K031688RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE2Cleared 510(K)
- K031398IS-1 HEMOSTASIS VALVE, MODEL 67992Cleared 510(K)
- K030077GISH TUBING AND CONNECTORS WITH GBS COATING2Cleared 510(K)
- K022918ADAPTERS WITH X-COATING2Cleared 510(K)
- K021282LV-1 HEMOSTASIS VALVE, MODEL #67892Cleared 510(K)
- K003604ADAPTERS WITH X-COATING2Cleared 510(K)
- K992906COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT2Cleared 510(K)
- K993057MBA2Cleared 510(K)
- K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 10033312Cleared 510(K)
- K972654MANIFOLD2Cleared 510(K)
- K963749HIGH PRESSURE INJECTION LINES2Cleared 510(K)
- K961181NMI VEIN GRAFT PERFUSION SET2Cleared 510(K)
- K955554HEMO-VALVE2Cleared 510(K)
- K954284MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)2Cleared 510(K)
- K953564MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE2Cleared 510(K)
- K952531QUEST VEIN GRAFT PERFUSION SET2Cleared 510(K)
- K942391BRAUN MANIFOLD2Cleared 510(K)
- K951089SCIMED GATEWAY PLUS2Cleared 510(K)
- K945931RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE2Cleared 510(K)
- K945461PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)2Cleared 510(K)
- K911884ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES2Cleared 510(K)
- K933084CHECK VALVE (FITTING)2Cleared 510(K)
- K934123STOPCOCK (ONE-PORT MANIFOLD)2Cleared 510(K)
- K922840ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS2Cleared 510(K)
- K925419PASSAGE HEMOSTASIS VALVE2Cleared 510(K)
- K915301ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK2Cleared 510(K)
- K914987HIGH PRESSURE CONNECTING SETS, MODIFICATION2Cleared 510(K)
- K913363CUSTOM TUBING PACKS2Cleared 510(K)
- K912969TORQUE FITTING2Cleared 510(K)
- K913161MERIT MANIFOLD2Cleared 510(K)
- K912709MX 339 TWIN HEMOSTATIC Y CONNECTOR2Cleared 510(K)
- K910845ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 10122Cleared 510(K)
- K902741VASCUMED EZ Y-CONNECTOR2Cleared 510(K)
- K900994ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.2Cleared 510(K)
- K900652NAMIC PTCA Y-ADAPTOR2Cleared 510(K)
- K897196ADVANCE STOPCOCKS ADVANCE MANIFOLDS2Cleared 510(K)
- K897137RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING2Cleared 510(K)
- K897197ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.2Cleared 510(K)
- K895795HPD TUBING CONNECTORS2Cleared 510(K)
- K892377RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET2Cleared 510(K)
- K892368RMI CARDIOPLEGIA DELIVERY SETS2Cleared 510(K)
- K893683SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM2Cleared 510(K)
- K891572ANGIOGRAPHY CUSTOM PACKS2Cleared 510(K)
- K890676DISPOSABLE TRANSDUCER MANIFOLD2Cleared 510(K)
- K890580LIPID STOPCOCK2Cleared 510(K)
- K884408NAMIC DUAL BACKCHECK VALVE2Cleared 510(K)
- K882717PROCEDURE PACKS CONTRAST MEDIA SETS2Cleared 510(K)
- K884200USCI TANDEM ADAPTER2Cleared 510(K)
- K883956BIO-MEDICUS TUBING CONNECTORS2Cleared 510(K)
- K880831LARGE LUMEN Y ADAPTER W/ROTATING DEVICE2Cleared 510(K)
- K873971ROTATING HEMOSTATIC VALVE2Cleared 510(K)
- K873488SILENT GUARD CAT. NO. SG-102Cleared 510(K)
- K872161DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET2Cleared 510(K)
- K870325#014160-TAB TUBING ROTATOR ADAPTOR2Cleared 510(K)
- K870073MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB2Cleared 510(K)
- K862451LUER LOCK SKIRT2Cleared 510(K)
- K863402MEDI-PLAST DISPOSABLE MANIFOLD2Cleared 510(K)
- K863177CORDIS ANGIOPLASTY HEMOSTASIS DEVICES2Cleared 510(K)
- K863661MEDCOMP DISPOSABLE MANIFOLD SYSTEM2Cleared 510(K)
- K861783DISPOSABLE STOPCOCK2Cleared 510(K)
- K860291TUBING CONNECTORS2Cleared 510(K)
- K854960DISPOSABLE MANIFOLD2Cleared 510(K)
- K853749CUSTOM CORONARY MANIFOLD KITS2Cleared 510(K)
- K854397HEMOSTATIC SIDEARM2Cleared 510(K)
- K853950ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL2Cleared 510(K)
- K854261ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES2Cleared 510(K)
- K853099L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION2Cleared 510(K)
- K853586PRESSURE SENSING SYRINGE 650002Cleared 510(K)
- K852086CAPIOX BLOOD SAMPLING MANIFOLD2Cleared 510(K)
- K851465SILENT GUARD CAT. NO. SG-302Cleared 510(K)
- K852118MANIFOLD CLAMPS2Cleared 510(K)
- K833644FILTER PURGE LINE EC-FPL SERIES2Cleared 510(K)
- K842829HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS2Cleared 510(K)
- K840797MALE-MALE LUER LOCK CONNECTOR W/ROTA2Cleared 510(K)
- K840603ARTERIAL FILTER PURGE LINE W/CHECK VALV2Cleared 510(K)
- K833322TUBING CONNECTORS EC-2XXX SERIES2Cleared 510(K)
- K832625TOP THREE WAY STOPCOCK2Cleared 510(K)
- K831260SCI MED TEMPERATURE MONITORING ADAPTOR2Cleared 510(K)
- K831261SCI MED TUBING CONNECTORS2Cleared 510(K)
- K820864NORTON MANIFOLD2Cleared 510(K)
- K820297WM. HARVEY OVERPRESSURE SAFETY VALVE2Cleared 510(K)
- K812408L.O.N. DISPOSABLE CORONARY MANIFOLD2Cleared 510(K)
- K812407L.O.N. REUSABLE MANIFOLDS & STOPCOCKS2Cleared 510(K)
- K813141VYGON STOPCOCKS & RAMPS(MANIFOLDS)2Cleared 510(K)
- K802544DISPOSABLE QUICK RELEASE PERFUSION ADAP2Cleared 510(K)
- K801828MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS2Cleared 510(K)
- K801402QUICKIE PRIME CARDIOP. BYPASS PERF. INTR2Cleared 510(K)
- K801405DISPOSABLE PERFUSION CONNECTORS2Cleared 510(K)
- K801404DISPOSABLE PARALLEL Y CONNECTORS2Cleared 510(K)
- K801399CORONARY PERFUSION CONNECTOR PLUG2Cleared 510(K)
- K801200SAMPLING MANIFOLD H5302Cleared 510(K)
- K800880PLASTIC TUBING ADAPTERS 5-IN-1-2Cleared 510(K)
- K792113CONPHAR MANOMETER CONNECTORS2Cleared 510(K)
- K7919143-WAY STOPCOCK W/MALE LOCKING LUER ADA.2Cleared 510(K)
- K791797MTS CATHETER ADAPTER FOR GUIDANCE ENTRY2Cleared 510(K)
- K791498ADAPTER-Y TYPE/CORONARY PERFUSION2Cleared 510(K)
- K791107STOPCOCK, THREE WAY2Cleared 510(K)
- K790804PURGE LINE UNIT2Cleared 510(K)
- K790564ADAPTER-STRAIGHT2Cleared 510(K)
- K790563ADAPTERS-Y-TYPE2Cleared 510(K)
- K782095STOPCOCKS, MANIFOLDS2Cleared 510(K)
- K781579MODIFIED STERILE DISPOSABLE STOPCOCKS2Cleared 510(K)
- K780271COBE STOPCOCK2Cleared 510(K)
- K780056OXYGENATOR HOLDER2Cleared 510(K)
- K772299TRANSPARENT MANIFOLD2Cleared 510(K)
- K760843PALEY TRANSPARENT MANIFOLD2Cleared 510(K)
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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SCIMED GATEWAY PLUS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K951089
- 510(k) Type
- Traditional
- Applicant
- SCIMED LIFE SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/31/1995
- Days to Decision
- 83 days
- Submission Type
- Summary