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
- 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
- K232562PowerWire Radiofrequency Guidewire Kit2Cleared 510(K)
- K230159SoundBite® Crossing System XS Peripheral2Cleared 510(K)
- K230594Tigereye ST CTO-Crossing Catheter2Cleared 510(K)
- K221163Tunnel Crossing Catheter2Cleared 510(K)
- K221541LimFlow ARC2Cleared 510(K)
- K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)2Cleared 510(K)
- K211802GoBack Crossing Catheter2Cleared 510(K)
- K212468Tigereye CTO-Crossing Catheter2Cleared 510(K)
- K203363Crosser iQ CTO Recanalization System2Cleared 510(K)
- K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)2Cleared 510(K)
- K210839SoundBite Crossing System - Peripheral (14P)2Cleared 510(K)
- K201330Tigereye CTO-Crossing Catheter2Cleared 510(K)
- K192211SoundBite Console, SoundBite Active Wire 182Cleared 510(K)
- K183357XableCath Crossing Catheter2Cleared 510(K)
- K170349RA-308 Excimer Laser System, Excimer Laser Catheter2Cleared 510(K)
- K162418Pioneer Plus Catheter2Cleared 510(K)
- K161208CROSSER CTO Recanalization Catheter2Cleared 510(K)
- K150187ELITECROSS Support Catheter2Cleared 510(K)
- K150836OUTBACK Elite Re-Entry Catheter2Cleared 510(K)
- K140438MICRO GUIDE CATHETER ELITE2Cleared 510(K)
- K140185OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE2Cleared 510(K)
- K140288TRUEPATH CTO DEVICE2Cleared 510(K)
- K131914OFFROAD RE-ENTRY CATHETER SYSTEM2Cleared 510(K)
- K123532OCELOT PIXL CATHETER2Cleared 510(K)
- K123462OCELOT CATHETER2Cleared 510(K)
- K122380OCELOT SYSTEM2Cleared 510(K)
- K120533BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES2Cleared 510(K)
- K120273KITTYCAT CATHETER, KITTYCAT 2 CATHETER2Cleared 510(K)
- K113838WILDCAT CATHETER2Cleared 510(K)
- K112308CROSSER RECANALIZATION SYSTEM2Cleared 510(K)
- K111338WILDCAT CATHETER2Cleared 510(K)
- K101599RVT CTO DEVICE2Cleared 510(K)
- K101615POWERWIRE RADIOFREQUENCY GUIDEWIRE2Cleared 510(K)
- K101777PIONEER PLUS CATHETER, MODEL PLUS 1202Cleared 510(K)
- K092175THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN2002Cleared 510(K)
- K091119MODIFICATION TO THE CROSSER SYSTEM2Cleared 510(K)
- K083814OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB421202Cleared 510(K)
- K082143MICRO GUIDE CATHETER XP2Cleared 510(K)
- K081804PIONEER PLUS CATHETER2Cleared 510(K)
- K072776THE CROSSER SYSTEM2Cleared 510(K)
- K072155PIONEER CATHETER2Cleared 510(K)
- K071227CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-152Cleared 510(K)
- K0712268FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-0432Cleared 510(K)
- K060012CLIRPATH TURBO PERIPHERAL CATHETERS2Cleared 510(K)
- K051670RF TUNNELER WIRE2Cleared 510(K)
- K052514CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-0012Cleared 510(K)
- K052296CLIRPATH TURBO EXCIMER LASER CATHETERS2Cleared 510(K)
- K0434652.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-0112Cleared 510(K)
- K050916SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]2Cleared 510(K)
- K040067CLIRPATH EXCIMER LASER CATHETER2Cleared 510(K)
- K033535LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES2Cleared 510(K)
- K031842SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM2Cleared 510(K)
- K031005LUMEND FRONTRUNNER GW CTO CATHETER2Cleared 510(K)
- K023114LUMEND FRONTRUNNER CTO CATHETER2Cleared 510(K)
- 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
- 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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SoundBite Console, SoundBite Active Wire 18
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192211
- 510(k) Type
- Traditional
- Applicant
- SoundBite Medical Solution Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/17/2020
- Days to Decision
- 156 days
- Submission Type
- Summary