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
- K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)2Cleared 510(K)
- K170027Inflation Device2Cleared 510(K)
- K162272Fluent inflation device2Cleared 510(K)
- K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit2Cleared 510(K)
- K153672basixTOUCH40 Inflation Syringe2Cleared 510(K)
- K152387Fluent Inflation Device2Cleared 510(K)
- K140943MASTRO PLUS BALLOON IN-DEFLATION DEVICE2Cleared 510(K)
- K143522Presto Inflation Device2Cleared 510(K)
- K133795SUMMED INFLATION DEVICE KIT2Cleared 510(K)
- K140745ENCORE 26 ADVANTAGE KIT2Cleared 510(K)
- K130566BASIXTOUCH2Cleared 510(K)
- K122321BASIXCONPAK ANALOG INFLATION SYRINGE2Cleared 510(K)
- K122152OXTI INFLATION DEVICE2Cleared 510(K)
- K123214ENCORE 26 ADVANTAGE KIT2Cleared 510(K)
- K120694ENCORE 26 ADVANTAGE KIT2Cleared 510(K)
- K102648ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK2Cleared 510(K)
- K082755SEDAT FLAMINGO2Cleared 510(K)
- K060643QL LOCKING SYRINGE2Cleared 510(K)
- K042449DOLPHIN INFLATION DEVICE2Cleared 510(K)
- K040138VICEROY INFLATION DEVICE2Cleared 510(K)
- K012480VANGUARD REPROCESSED INFLATION DEVICES2Cleared 510(K)
- K993341INTELLISYSTEM II COLOR MONITOR2Cleared 510(K)
- K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)2Cleared 510(K)
- K960983MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT2Cleared 510(K)
- K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)2Cleared 510(K)
- K953522USCI IDEAL PTCA KIT2Cleared 510(K)
- K953676BREEZE DIGITAL INFLATION DEVICE2Cleared 510(K)
- K955869SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE2Cleared 510(K)
- K952566OSCILFLATOR2Cleared 510(K)
- K943597MONARCH AP(TM)2Cleared 510(K)
- K942269MEDTRONIC EVEREST INFLATION DEVICE2Cleared 510(K)
- K940896MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE2Cleared 510(K)
- K940425IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING2Cleared 510(K)
- K921757ANGEION IGITAL ANGEFLATOR2Cleared 510(K)
- K92257310 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE2Cleared 510(K)
- K921719ACS ANGIOTRAK(TM) SYSTEM2Cleared 510(K)
- K913994MONARCH(TM) INFLATION SYRINGE2Cleared 510(K)
- K912644CORDIS INFLATOR DEVICE2Cleared 510(K)
- K911295ANGIOPLASTY INFLATOR2Cleared 510(K)
- K910958MEDFLATOR INFLATION SYSTEM2Cleared 510(K)
- K912544BIPOLAR FORCEPS2Cleared 510(K)
- K904508CONDOR ANALOG INFLATION SYRINGE2Cleared 510(K)
- K910205LP-60 LOW PRESSURE INFLATION DEVICE2Cleared 510(K)
- K904954CONDOR DIGITAL INFLATION SYRINGE2Cleared 510(K)
- K904275MORSE BALLOON INFLATION DEVICE2Cleared 510(K)
- K903621MAGNUM-20 (TM) INFLATION DEVICE2Cleared 510(K)
- K904394INFLATION/DEFLATION DEVICE2Cleared 510(K)
- K902695DISPOSABLE INFLATION GAUGE2Cleared 510(K)
- K903503SCIMED ENCORE INFLATION DEVICE, MODEL SM25002Cleared 510(K)
- K896849ACS INDEFLATOR XX2Cleared 510(K)
- K895511CATHETER BALLOON DILATOR PRESSURE GAUGE2Cleared 510(K)
- K896005SMALL CATHETER INFLATOR2Cleared 510(K)
- K895836INFLATION PRO II2Cleared 510(K)
- K861607SCHNEIDER-SHILEY INFLATION SYRINGES2Cleared 510(K)
- K853136MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)2Cleared 510(K)
- K843448SCIMED PM200 INFLATION MANOMETER2Cleared 510(K)
- K832323EDSLAB PRESSURE GAUGE2Cleared 510(K)
- K812304DORROS-SPRING PRESSURIZER2Cleared 510(K)
- 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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ACS ANGIOTRAK(TM) SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K921719
- 510(k) Type
- Traditional
- Applicant
- ADVANCED CARDIOVASCULAR SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/7/1992
- Days to Decision
- 120 days
- Submission Type
- Summary