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
- K250590MAGiC Sweep™ EP Mapping Catheter2Cleared 510(K)
- K250310VIKING™ Fixed Curve Diagnostic Catheter2Cleared 510(K)
- K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter2Cleared 510(K)
- K233900Nordica PV Cryo Mapping Catheter2Cleared 510(K)
- K233397Cosine-10TM Diagnostic Catheter2Cleared 510(K)
- K233207Polaris X™ Unidirectional Steerable Diagnostic Catheter2Cleared 510(K)
- K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter2Cleared 510(K)
- K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable2Cleared 510(K)
- K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter2Cleared 510(K)
- K220796IntellaMap Orion High Resolution Mapping Catheter2Cleared 510(K)
- K203793RithmID-SD Steerable Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters2Cleared 510(K)
- K211219LASSOSTAR NAV Circular Mapping Catheter2Cleared 510(K)
- K212593ViaCath, AcQRate Dx Steerable Catheter2Cleared 510(K)
- P990025Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter2PMA Approval
- P990025CELSIUS and EZ STEER2PMA Approval
- K211494Polaris X Unidirectional Steerable Diagnostic Catheter2Cleared 510(K)
- K211375Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter2Cleared 510(K)
- K201445MultiCath, AcQRate Dx Fixed Curve Catheter2Cleared 510(K)
- P990025Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar2PMA Approval
- P990025Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter2PMA Approval
- P990025NAVISTAR™RMT THERMOCOOL, NAVISTAR™DS, EZ STEER™NAV DS2PMA Approval
- P990025Navistar, Navistar RMT, EZ Steer Nav Bi-directional2PMA Approval
- K203261Reprocessed Inquiry Steerable Diagnostic EP Catheter2Cleared 510(K)
- P990025Navistar EP, EZ Steer Nav Bi-Directional2PMA Approval
- P990025EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter2PMA Approval
- K193632LassoStar Circular Mapping Catheter2Cleared 510(K)
- P990025EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables2PMA Approval
- P990025Navistar Electrophysiology Catheter2PMA Approval
- K191880Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K192360IntellaMap Orion High Resolution Mapping Catheter2Cleared 510(K)
- K192037Advisor VL Circular Mapping Catheter, Sensor Enabled2Cleared 510(K)
- K190132Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter2Cleared 510(K)
- K183547Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter2Cleared 510(K)
- K190980Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter2Cleared 510(K)
- K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable2Cleared 510(K)
- K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable2Cleared 510(K)
- K182386Reprocessed Supreme Diagnostic Electrophysiology Catheter2Cleared 510(K)
- P990025Navistar RMT Catheter2PMA Approval
- P990025Navistar RMT Electrophysiology Catheter2PMA Approval
- P990025Navi-Star Diagnostics/ Ablation Deflectable Tip Catheter2PMA Approval
- K171277Reprocessed Inquiry Steerable Diagnostic EP Catheter2Cleared 510(K)
- P990025Navi-Star Diagnostic/Ablation Deflectable Tip Catheter2PMA Approval
- P990025NaviStar Catheter2PMA Approval
- P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P990025EZ Steer Navigational 4mm (TC)2PMA Approval
- P990025NAVISTAR RMT; NAVISTAR RMT DS CATHETER2PMA Approval
- K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D2Cleared 510(K)
- K161769Reprocessed Supreme Diagnostic Electrophysiology Catheters2Cleared 510(K)
- K162892Achieve Advance Mapping Catheter2Cleared 510(K)
- K151139EasyMap MAP Catheter2Cleared 510(K)
- P990025NAVISTAR ELECTROPHYSIOLOGY CATHETER2PMA Approval
- K153139Achieve ST Mapping Catheter, Catheter Connecting Cable2Cleared 510(K)
- P990025NAVI-STAR and EZ Steer Nav Bi-Directional Catheter2PMA Approval
- K160390Map-it Diagnostic Mapping Catheters2Cleared 510(K)
- K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter2Cleared 510(K)
- K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter2Cleared 510(K)
- K143481IntellaMap Orion High Resolution Mapping Catheter2Cleared 510(K)
- K133028RITHM ID ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K130602LASSO NAV DUO LOOP CATHETER2Cleared 510(K)
- K122461RHYTHMIA MAPPING CATHETER2Cleared 510(K)
- K120544RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN2Cleared 510(K)
- K113213LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 22Cleared 510(K)
- K101991WEBSTER DUO-DECAPOLAR CATHETER2Cleared 510(K)
- K102588ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE2Cleared 510(K)
- K102721LIVEWIRE ELECTOPHYSIOLOGY CATHETER2Cleared 510(K)
- K101955ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D4020582Cleared 510(K)
- K101623INQUIRY AFOCUSII DIAGNOSTIC CATHETER2Cleared 510(K)
- K101345WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,2Cleared 510(K)
- K093376LASSO NAV CATHETER2Cleared 510(K)
- K090898CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER2Cleared 510(K)
- K091370RADIA STEERABLE DIAGNOSTIC CATHETER2Cleared 510(K)
- K081803ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM2Cleared 510(K)
- K090120REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-1062Cleared 510(K)
- K081576BLAZER DX-20 DIAGNOSTIC CATHETER2Cleared 510(K)
- K080179REFLEXION HD HIGH-DENSITY MAPPING CATHETER2Cleared 510(K)
- K081258VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-022Cleared 510(K)
- K082061INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER2Cleared 510(K)
- K080425CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-022Cleared 510(K)
- K072012REFLEXION SPIRAL VARIABLE RADIUS CATHETER2Cleared 510(K)
- K061678PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-252Cleared 510(K)
- K062251REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 4028042Cleared 510(K)
- K061468REFSTAR EXTERNAL REFERENCE PATCH2Cleared 510(K)
- K061463ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S2Cleared 510(K)
- K060047CARTO RMT EP NAVIGATION SYSTEM V82Cleared 510(K)
- K060757INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K053582INQUIRY AFOCUS II DIAGNOSTIC CATHETER2Cleared 510(K)
- P950005CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S2PMA Approval
- K052083NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER2Cleared 510(K)
- K042998REFSTAR RMT EXTERNAL REFERENCE PATCH2Cleared 510(K)
- K050877CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR2Cleared 510(K)
- P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR2PMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR2PMA Approval
- K043257REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM2Cleared 510(K)
- K042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K042105CLIPPER DIAGNOSTIC ELECTRODE CATHETER2Cleared 510(K)
- K033963EP DEFLECTABLE CATHETERS2Cleared 510(K)
- K033050EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL22Cleared 510(K)
- P990071STOCKERT 70 RADIOFREQUENCY GENERATOR2PMA Approval
- K030627ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 3201102Cleared 510(K)
- K031161VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER2Cleared 510(K)
- K0308524 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX2Cleared 510(K)
- P990025NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS2PMA Approval
- P950005NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS2PMA Approval
- K021421PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE2Cleared 510(K)
- P990025NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P950005CELSIUS AND CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P990025QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12)2PMA Approval
- P990025NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER2PMA Approval
- P950005NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER2PMA Approval
- P990071STOCKERT 70 RF GENERATOR WITH SOFTWARE VERSION 1.0332PMA Approval
- K022380LIVESIRE ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- P990025NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- K013484TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH2Cleared 510(K)
- K012520GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E2Cleared 510(K)
- P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR2PMA Approval
- P950005CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P990025NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER2PMA Approval
- K011361DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE2Cleared 510(K)
- K011847ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE2Cleared 510(K)
- K0117666F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 40272Cleared 510(K)
- K0117346-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX2Cleared 510(K)
- P950005CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND TEMPERATURE CABLES2PMA Approval
- P950005CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P950005CELSIUS II BIDIRECTIONAL DEFLECTING DIAGNOSTIC/ABLATION CATHETER2PMA Approval
- K010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 815692Cleared 510(K)
- P950005CELSIUS/CELSIUS II DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER\2PMA Approval
- K002976RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX2Cleared 510(K)
- K003452POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D2Cleared 510(K)
- P950005CORDIS WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- K002333BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-12202Cleared 510(K)
- K993698SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX2Cleared 510(K)
- P990071STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE2PMA Approval
- P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER2PMA Approval
- P950005BIOSENSE WEBSTER TEMPERATURE CABLES2PMA Approval
- K000753CORDIS 13F CATHETER SHEATH INTRODUCER2Cleared 510(K)
- K991060ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z500002Cleared 510(K)
- P950005CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR2PMA Approval
- K992912CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH2Cleared 510(K)
- P950005CELLSIUS INTERFACE CABLES (AUTOCLAVABLE)2PMA Approval
- K991878LUMA-CATH STEERABLE EP CATHETERS2Cleared 510(K)
- K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-10852Cleared 510(K)
- K992373ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE2Cleared 510(K)
- K991025LUMA-CATH FIXED CURVE EP CATHETERS2Cleared 510(K)
- K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-10782Cleared 510(K)
- K991001MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K990958ORTHOGONAL EP CATHETERS2Cleared 510(K)
- K972803TRACER O-T-W MAPPING DEVICE2Cleared 510(K)
- P950005CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE2PMA Approval
- K984150PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- P950005CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR2PMA Approval
- K983653RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D2Cleared 510(K)
- K982835ELECTRODE SWITCHBOX, MODEL 11-0810022Cleared 510(K)
- K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-12102Cleared 510(K)
- K981642STABLEMAPR STEERABLE INTRACARDIAC CATHETERS2Cleared 510(K)
- K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM2Cleared 510(K)
- P950005DIAGNOSTIC/ABLATION DEFLECTABLE BRAIDED-TIP CATHETER (WITHOUT THERMOCOUPLE) & CELSIUS (WITH THERMOCOUPLE)2PMA Approval
- K971975CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER2Cleared 510(K)
- K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.2Cleared 510(K)
- K973639ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.2Cleared 510(K)
- K971504HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER2Cleared 510(K)
- K970853PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)2Cleared 510(K)
- K971265VIKING DIAGNOSTIC ELECTRODE CATHETER2Cleared 510(K)
- K965066ARRHYTHMIA MAPPING SYSTEM (8100/8300)2Cleared 510(K)
- K963074HARMAC QUADPOLAR MAPPING PACING CATHETER2Cleared 510(K)
- K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM2Cleared 510(K)
- K955847GYRO TIP EP CATHETER2Cleared 510(K)
- K955802PATHFINDER2Cleared 510(K)
- K964272PERFORMR SERIES EP DIAGNOSTIC CATHETERS2Cleared 510(K)
- K954651ELECTRODE RECORDING CATHETER2Cleared 510(K)
- K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER2Cleared 510(K)
- K962307RHYDER DIAGNOSTIC CATHETER2Cleared 510(K)
- K960542NOGA2Cleared 510(K)
- K953185PLATINUM SERIES EP DIAGNOSTIC CATHETERS2Cleared 510(K)
- K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER2Cleared 510(K)
- K953750CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2Cleared 510(K)
- K954390CORDIS WESTER STAR CATHETER2Cleared 510(K)
- K953651DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM2Cleared 510(K)
- K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER2Cleared 510(K)
- K945229ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS2Cleared 510(K)
- K946333IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER2Cleared 510(K)
- K932388HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K951347MARINR SERIES EP DIAGNOSTI CATHETERS2Cleared 510(K)
- K951744LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS2Cleared 510(K)
- K933417ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K943257TIP DEFLECTOR (GENESIS)2Cleared 510(K)
- K933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION2Cleared 510(K)
- K933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION2Cleared 510(K)
- K942379DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K940167DIAGNOSTIC I CATHETER2Cleared 510(K)
- K940168DIAGNOSTIC II CATHETER2Cleared 510(K)
- K931794MARINR SERIES EP DIAGNOSTIC CATHETERS2Cleared 510(K)
- K924109STEEROCATH II2Cleared 510(K)
- K924108TRACFINDER II2Cleared 510(K)
- K926549ENDOCATH ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K924163EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC2Cleared 510(K)
- K923916VOYAGR SERIES DIAGNOSTIC EP CATHETERS2Cleared 510(K)
- K923915TORQR SERIES DIAGNOSTIC EP CATHETERS2Cleared 510(K)
- K911065ARROW QUADPOLAR MAPPING/PACING CATHETER2Cleared 510(K)
- K915640VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER2Cleared 510(K)
- K915563DIAGNOSTIC EP CATHETER2Cleared 510(K)
- K914278DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN2Cleared 510(K)
- K915159PEDIATRIC MULTI-FUNCTION ELECTRODES2Cleared 510(K)
- K914460MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES2Cleared 510(K)
- K913375TORQUE TUBE STEEROCATH(TM)2Cleared 510(K)
- K904747PEI PLAQUE ELECTRODE ARRAY2Cleared 510(K)
- K911140BARD(R) ENDOCARDIAL BALLOON ARRAY2Cleared 510(K)
- K905831ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH2Cleared 510(K)
- K903136ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER2Cleared 510(K)
- K903880FRANZ(TM) STEERABLE COMBINATION CATHETER2Cleared 510(K)
- K902228MODIFIED EPICARDIAL ARRAY2Cleared 510(K)
- K900765STEEROCATH(TM)2Cleared 510(K)
- K900452QUATTRO CATHETER2Cleared 510(K)
- K895916PE INTERCARDIAC MAPPING SYSTEM (ICMS)2Cleared 510(K)
- K894500DAIG ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K893611BARD PLAQUE ELECTRODE ARRAY2Cleared 510(K)
- K892207FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED2Cleared 510(K)
- K891908BARD(R) TIP DEFLECTING ELECTRODE CATHETER2Cleared 510(K)
- K881966ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER2Cleared 510(K)
- K881853FRANZ CATHETER2Cleared 510(K)
- K873995BARD DESAI CATHETER ELECTRODE2Cleared 510(K)
- K874208BARD OCTAPOLAR ELECTRODE CATHETER2Cleared 510(K)
- K872231BARD EPICARDIAL ELECTRODE ARRAY2Cleared 510(K)
- K844805ELECATH GALLAGHER MAPPING CATHETER2Cleared 510(K)
- K834602SWITCHING UNIT ELECTRODE CATHETER2Cleared 510(K)
- K831528MODEL TP THERMISTOR PROBE2Cleared 510(K)
- K823361SWITCHING UNIT ELECTRODE CATHETERS2Cleared 510(K)
- K823434MIKRO-TIP CATHETER PRESSURE TRANSDUCER2Cleared 510(K)
- K812944MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.2Cleared 510(K)
- K802058MAPPING PROBE MODEL #65402Cleared 510(K)
- K770709PROBE, TEMPERATURE, SYSTEM, SARNS2Cleared 510(K)
- K770477CITADEL REFERENCE ELECTRODE2Cleared 510(K)
- K770341TEMP. PROBE, & ELECTRONIC THERMOMETER2Cleared 510(K)
- 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
- 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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Polaris X Unidirectional Steerable Diagnostic Catheter
- Page Type
- Cleared 510(K)
- 510(k) Number
- K211494
- 510(k) Type
- Traditional
- Applicant
- Boston Scientific Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/14/2021
- Days to Decision
- 124 days
- Submission Type
- Summary