Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- K243534Micro Catheter2Cleared 510(K)
- K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)2Cleared 510(K)
- K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm2Cleared 510(K)
- K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mm2Cleared 510(K)
- K230957TriSalus TriNav® LV Infusion System2Cleared 510(K)
- K223139Wallaby 017 Micro Catheter2Cleared 510(K)
- K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister2Cleared 510(K)
- K230636Maestro Microcatheter2Cleared 510(K)
- K222679Vericor Support Catheter2Cleared 510(K)
- K213435MAGIC Flow-Dependent Microcatheter2Cleared 510(K)
- K213442Extroducer Infusion Catheter System2Cleared 510(K)
- K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter2Cleared 510(K)
- K212719Micro Catheter and Guidewire System2Cleared 510(K)
- K211110Agile Devices Angler Steerable, Deflectable Microcatheter2Cleared 510(K)
- K210838PROWLER SELECT PLUS; PROWLER EX2Cleared 510(K)
- K210339Bullfrog Micro-Infusion Device2Cleared 510(K)
- K211525SwiftNINJA Steerable Microcatheter2Cleared 510(K)
- K210808Instylla Microcatheter 1.22Cleared 510(K)
- K210114Rebar Micro Catheter2Cleared 510(K)
- K202366MAGIC Infusion Catheter2Cleared 510(K)
- K202318Marathon Flow Directed Micro Catheter2Cleared 510(K)
- K193082Fountain ValveTip Infusion Catheter2Cleared 510(K)
- K201907ClariVein IC2Cleared 510(K)
- K201792TRUSELECT Microcatheter2Cleared 510(K)
- K200582Bendit2.7 Steerable Microcatheter2Cleared 510(K)
- K200744Instylla Microcatheter2Cleared 510(K)
- K191305Hereaeus Poseidon Microcatheter2Cleared 510(K)
- K193107TriSalus Infusion System2Cleared 510(K)
- K191731Instylla Microcatheter2Cleared 510(K)
- K182071Multi-Sideport Catheter Infusion Set2Cleared 510(K)
- K181684VAMP Plus Venous/Arterial Blood Management Protection System2Cleared 510(K)
- K180275VAMP Optima closed blood sampling system2Cleared 510(K)
- K173586VAMP Venous/Arterial Blood Management Protection System2Cleared 510(K)
- K171665Microcatheter and guide-wire system2Cleared 510(K)
- K170931CXI TriForce Peripheral Crossing Set2Cleared 510(K)
- K172081Maestro Microcatheter2Cleared 510(K)
- K163701Direxion and Direxion HI-FLO Torqueable Microcatheters2Cleared 510(K)
- K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm2Cleared 510(K)
- K161962VAMP Venous/Arterial Blood Management Protection System2Cleared 510(K)
- K160884CXI Support Catheter2Cleared 510(K)
- K161921SwiftNINJA Microcatheter2Cleared 510(K)
- K161402Bullfrog Micro-Infusion Device2Cleared 510(K)
- K161801CrossCath Support Catheter2Cleared 510(K)
- K153501Bullfrog Micro-Infusion Device2Cleared 510(K)
- K152625MMS Guide Catheter2Cleared 510(K)
- K153502ClariVein IC2Cleared 510(K)
- K142259Direxion Torqueable Microcatheter2Cleared 510(K)
- K140329RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT2Cleared 510(K)
- K140637PEREGRINE SYSTEM INFUSION CATHETER2Cleared 510(K)
- K131772CANTATA(R) 2.9 MICROCATHETER2Cleared 510(K)
- K130569ND NABIL DIB INFUSION CATHETER2Cleared 510(K)
- K132947DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS2Cleared 510(K)
- K123477VIA MICROCATHETER, VIA PLUS MICROCATHETER2Cleared 510(K)
- K122796CXI SUPPORT CATHETER2Cleared 510(K)
- K113289ORION MICRO CATHETER2Cleared 510(K)
- K113773ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL2Cleared 510(K)
- K111490MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS2Cleared 510(K)
- K111263CXI TRIFORCE2Cleared 510(K)
- K101450CANTATA MICROCATHETER2Cleared 510(K)
- K100892RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX2Cleared 510(K)
- K093750ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA2Cleared 510(K)
- K093052CROSSCATH SUPPORT CATHTER2Cleared 510(K)
- K091559MARKSMANN CATHETER2Cleared 510(K)
- K081147ISOFLOW INFUSION CATHETER2Cleared 510(K)
- K090870ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY2Cleared 510(K)
- K082613MERIT MICROCATHETER2Cleared 510(K)
- K082163FLOWMEDICA BENEPHIT INFUSION SYSTEMS2Cleared 510(K)
- K082519FINECROSS MG CORONARY MICRO-GUIDE CATHETER2Cleared 510(K)
- K080737MIRAFLEX HIGH FLOW MICROCATHETER2Cleared 510(K)
- K053310VASCON ROAMER MICROCATHETER2Cleared 510(K)
- K073166ENDOWAVE INFUSION SYSTEM2Cleared 510(K)
- K071468CLARIVEIN CATHETER2Cleared 510(K)
- K073400VARICATH PERIPHERAL INFUSION CATHETER2Cleared 510(K)
- K072724CXI SUPPORT CATHETER2Cleared 510(K)
- K070979PULL TAB SQUEEZE FLUSH2Cleared 510(K)
- K070384ARGON CONTINUOUS FLUSH DEVICE2Cleared 510(K)
- K070279MODIFICATION TO HYPERTRANSIT INFUSION CATHETER2Cleared 510(K)
- K062752MERCATOR MICROSYRINGE II INFUSION CATHETER2Cleared 510(K)
- K060224MODIFICATION TO MIRA-FLEX 18 MICROCATHETER2Cleared 510(K)
- K051990ECHELON MICRO CATHETER2Cleared 510(K)
- K052841MIRA-FLEX 18 MICROCATHETER2Cleared 510(K)
- K052738INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF00442Cleared 510(K)
- K043538HYPERTRANSIT INFUSION CATHETER2Cleared 510(K)
- K050630PIVOT STEERABLE MICROCATHETER2Cleared 510(K)
- K050205BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH2Cleared 510(K)
- K042187ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,902Cleared 510(K)
- K033913PROGREAT2Cleared 510(K)
- K040139ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER2Cleared 510(K)
- K034036MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-50552Cleared 510(K)
- K033726PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER2Cleared 510(K)
- K033569FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH2Cleared 510(K)
- K032494PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER2Cleared 510(K)
- K031992ECHELON MICRO CATHETER, MODEL 105-50912Cleared 510(K)
- K030688ECHELON MICRO CATHETER, MODEL 105-5092-1502Cleared 510(K)
- K024122NAUTICA MICRO CATHETER, MODEL 105-5094-1532Cleared 510(K)
- K023351MAGIC INFUSION CATHETER2Cleared 510(K)
- K024118ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-50662Cleared 510(K)
- K021591PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS2Cleared 510(K)
- K020680PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS2Cleared 510(K)
- K020733PVS 1500 SDS2Cleared 510(K)
- K011646NEUROEDGE INFUSION CATHETER2Cleared 510(K)
- K010004FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-50652Cleared 510(K)
- K003925PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS2Cleared 510(K)
- K002723REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA2Cleared 510(K)
- K994155EXCELSIOR 1018 MICROCATHETER2Cleared 510(K)
- K001966REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND2Cleared 510(K)
- K000177RENEGADE HI-FLO MICROCATHETER2Cleared 510(K)
- K993672REBAR MICRO CATHETER, MODELS 105-5080, 105-50862Cleared 510(K)
- K993266PROWLER PLUS INFUSION CATHETER2Cleared 510(K)
- K9830031 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS2Cleared 510(K)
- K974473EASY RIDER MICRO CATHETER2Cleared 510(K)
- K980104FLOW RIDER FLOW DIRECTED MICRO CATHETER2Cleared 510(K)
- K971619MICROFUSE MEMBRANE INFUSION CATHETER2Cleared 510(K)
- K974222CES MASSTRANSIT INFUSION CATHETER2Cleared 510(K)
- K973645RENEGADE FIBER BRAIDED MICROCATHETER2Cleared 510(K)
- K972518TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER2Cleared 510(K)
- K971306FG INFUSION CATHETER2Cleared 510(K)
- K9648682.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER2Cleared 510(K)
- K962129CONTINUOUS FLUSH DEVICE2Cleared 510(K)
- K965189SPINNAKER2Cleared 510(K)
- K965181CES INFUSION CATHETER2Cleared 510(K)
- K964154SEGUE INFUSION CATHETER2Cleared 510(K)
- K963988INTRAVASCULAR INFUSION DEVICE2Cleared 510(K)
- K961668MICROFERRET CATHETER2Cleared 510(K)
- K955525FLOWER INFUSION CATHETER MODEL F-25/50, F-60/702Cleared 510(K)
- K955534SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)2Cleared 510(K)
- K961294SCIMED DISPATCH GOLD CORONARY CATHETER2Cleared 510(K)
- K961527MX703 AND MX730 CONTINUOUS FLUSH DEVICES2Cleared 510(K)
- K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER2Cleared 510(K)
- K953133SCIMED DISPATCH CORONARY INFUSION CATHETER2Cleared 510(K)
- K954020MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE2Cleared 510(K)
- K954949TRANSIT INFUSION CATHETER WITH SIDEHOLES2Cleared 510(K)
- K953384PERCUTANEOUS CATHETER INFUSION SYSTEM2Cleared 510(K)
- K952874TRANSIT INFUSION CATHETER2Cleared 510(K)
- K952872SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER2Cleared 510(K)
- K952317INFUSASLEEVE II2Cleared 510(K)
- K945666EVOLUTION(TM) MICROCATHETER2Cleared 510(K)
- K951509PULSE SPRAY INFUSION SYSTEM2Cleared 510(K)
- K951602PULSE SPRAY INFUSION SYSTEM2Cleared 510(K)
- K945909NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER2Cleared 510(K)
- K945904SCIMED(R) VENTURE(TM) II INFUSION CATHETER2Cleared 510(K)
- K950907PULSE*SPRAY INFUSION SYSTEM2Cleared 510(K)
- K951502CVD BULLET INFUSION CATYHETER2Cleared 510(K)
- K951503CVD BULLETT HI-FLO INFUSION CATHETER2Cleared 510(K)
- K950615KAPLAN-SIMPSON INFUSASLEEVE CATHETER2Cleared 510(K)
- K945593SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER2Cleared 510(K)
- K935349LOCALMED INFUSION CATHETER2Cleared 510(K)
- K931335SCIMED(R) VENTURE(TM) INFUSION CATHETER2Cleared 510(K)
- K932800CARDIMA TRACKER(R) INFUSION CATHETER2Cleared 510(K)
- K932616SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER2Cleared 510(K)
- K932188SAFESET RESERVOIR2Cleared 510(K)
- K921247ZEPHYR INFUSION CATHETER2Cleared 510(K)
- K914751SELECTIVE INFUSION II CATHETER2Cleared 510(K)
- K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER2Cleared 510(K)
- K923368MAGIC INFUSION CATHETER2Cleared 510(K)
- K914979EDM(R) INFUSION CATHETER2Cleared 510(K)
- K905447E-Z-EM PULSED INFUSION SYSTEM2Cleared 510(K)
- K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION2Cleared 510(K)
- K885281VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION2Cleared 510(K)
- K884946JEHLE CORONARY PERFUSION CATHETERS2Cleared 510(K)
- K874242JEHLE CORONARY PERFUSION CATHETERS2Cleared 510(K)
- K860570ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE2Cleared 510(K)
- K832058ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.2Cleared 510(K)
- K831730CONTINUOUS FLUSH DEVICE2Cleared 510(K)
- K831637ACCU-FLUSH2Cleared 510(K)
- K812173FLUSHFLO II2Cleared 510(K)
- K811410MEDI-TRACE2Cleared 510(K)
- K801829MEDI-TRACE DISP. FLUSHING DEV./MONITOR2Cleared 510(K)
- K801173ANGIO-FLO MONITORING KIT2Cleared 510(K)
- K791890CONTINUOUS FLUSH DEVICE, CAT. #14-3702Cleared 510(K)
- K792141CONTINUOUS FLUSH DEVICE2Cleared 510(K)
- K791844CRITIFLO & CRITIFLO DOME2Cleared 510(K)
- K790455MICROFLUSH2Cleared 510(K)
- K790327ANGIO-FLO2Cleared 510(K)
- K780479DELTA-FLOW2Cleared 510(K)
- K770432MICROFLUSH2Cleared 510(K)
- K761273FLUSHFLO-MODEL CC1-62Cleared 510(K)
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- NPGCatheter, Infusion, Syringe2Product Code
- 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
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Extroducer Infusion Catheter System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K213442
- 510(k) Type
- Traditional
- Applicant
- Smartwise Sweden AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/10/2022
- Days to Decision
- 228 days
- Submission Type
- Summary