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
- 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
- K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)2Cleared 510(K)
- K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)2Cleared 510(K)
- K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)2Cleared 510(K)
- K232132LifeSPARC System2Cleared 510(K)
- K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors2Cleared 510(K)
- K200091Capiox iCP Centrifugal Pump2Cleared 510(K)
- K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor2Cleared 510(K)
- K193663FloPump 57mL Centrifugal Pump2Cleared 510(K)
- K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP222Cleared 510(K)
- K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface2Cleared 510(K)
- K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP222Cleared 510(K)
- K191077Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor2Cleared 510(K)
- K190650Revolution Centrifugal Blood Pump2Cleared 510(K)
- K183623LifeSPARC Pump, LifeSPARC Controller2Cleared 510(K)
- K170029FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile2Cleared 510(K)
- K132712AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER2Cleared 510(K)
- K133265QUADROX-IR ADULT AND SMALL ADULT2Cleared 510(K)
- K112229SARN CENTRIFUGAL PUMP2Cleared 510(K)
- K110493TANDEMHEART PUMP2Cleared 510(K)
- K111972AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF2Cleared 510(K)
- K111658AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE2Cleared 510(K)
- K111657AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE2Cleared 510(K)
- K111384LIFEBRIDGE2Cleared 510(K)
- K110845IMPELLA CONTROLLER WITH FLOW CONTROL2Cleared 510(K)
- K103357LIFEBRIDGE2Cleared 510(K)
- K093801IMPELLA CONTROLLER2Cleared 510(K)
- K100631AFFIITY CP CENTRIFUGAL BLOOD PUMP2Cleared 510(K)
- K090515ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)2Cleared 510(K)
- K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-900522Cleared 510(K)
- K083794MECC SET WITH BIOLINE COATING2Cleared 510(K)
- K083111IMPELLA 5.0 CATHETER FAMILY2Cleared 510(K)
- K082321TERUMO ROCSAFE HYBRID PERFUSION SYSTEM2Cleared 510(K)
- K080470ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-322Cleared 510(K)
- K073631ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-1002Cleared 510(K)
- K063723IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM2Cleared 510(K)
- K080774CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)2Cleared 510(K)
- K061072ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-322Cleared 510(K)
- K051209LEVITRONIX CENTRIMAG BACK-UP CONSOLE2Cleared 510(K)
- K050890ECC.O SYSTEM2Cleared 510(K)
- K050109TRILLIUM BIOPUMP PLUS, MODEL BPX80T2Cleared 510(K)
- K033270NOVOSCI READY SYSTEM, MODEL RS-2002Cleared 510(K)
- K032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR2Cleared 510(K)
- K031300IBC FLOPUMP WITH GBS COATING2Cleared 510(K)
- K030154IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR2Cleared 510(K)
- K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-1002Cleared 510(K)
- K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 0503007002Cleared 510(K)
- K023132JOSTRA MECC SYSTEM2Cleared 510(K)
- K020529LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-22Cleared 510(K)
- K012325CARDIOVENTION CORX SYSTEM, MODEL FG 00012Cleared 510(K)
- K020998SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X2Cleared 510(K)
- K011835COBE REVOLUTION2Cleared 510(K)
- K013393HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H2Cleared 510(K)
- K012209CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X2Cleared 510(K)
- K991783AB-180 XC SYSTEM, MODEL AB-180XC2Cleared 510(K)
- K991864ROTAFLOW CENTRIFUGAL PUMP SYSTEM2Cleared 510(K)
- K992592A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 20002Cleared 510(K)
- K983272IBC FLOPUMP, MODEL 60002Cleared 510(K)
- K973011BPX80 BIO-PUMP (BPX80)2Cleared 510(K)
- K972740HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)2Cleared 510(K)
- K962981CAPIOX SP PUMP HEAD2Cleared 510(K)
- K952879SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT2Cleared 510(K)
- K943861CAPIOX SP PUMP HEAD2Cleared 510(K)
- K933014LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI2Cleared 510(K)
- K915547SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT2Cleared 510(K)
- K915363SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)2Cleared 510(K)
- K921550LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP2Cleared 510(K)
- K913176DELPHIN II CENTRIFUGAL SYSTEM2Cleared 510(K)
- K912604SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF2Cleared 510(K)
- K903925ARIES MELDICAL MODEL 2100HC HANK CRANK2Cleared 510(K)
- K902404SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW2Cleared 510(K)
- K902198SARNS DELPHIN BASE ADAPTER WITH BATTERY2Cleared 510(K)
- K900601SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY2Cleared 510(K)
- K894255ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP2Cleared 510(K)
- K884659SARNS 9000 WITH CENTRIFUGAL PUMP OPTION2Cleared 510(K)
- K882129SYMBION CENTRIFUGAL BLOOD PUMP MODEL I2Cleared 510(K)
- K882758CENTRIFUGAL PUMP SYSTEM LX/DX VERSION2Cleared 510(K)
- K854975ELECATH PULSATILE PERFUSION PUMP2Cleared 510(K)
- K852807BIO MEDICUS BIO PUMP MODEL BP-502Cleared 510(K)
- K852698BIO MEDICUS BIO PUMP MODEL BP-802Cleared 510(K)
- K851855BIO MEDICUS BIO PUMP MODEL BP-902Cleared 510(K)
- K851613CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER2Cleared 510(K)
- K842007CENTRIMED SYSTEM 12Cleared 510(K)
- K780953MODEL 1861 BLOOD PUMP2Cleared 510(K)
- K770937PUMP, BYPASS, PULSATILE, AVCO2Cleared 510(K)
- 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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- PathologyReview Panel
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- UnknownReview Panel
TANDEMHEART PUMP
- Page Type
- Cleared 510(K)
- 510(k) Number
- K110493
- 510(k) Type
- Traditional
- Applicant
- CARDIACASSIST INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/20/2011
- Days to Decision
- 210 days
- Submission Type
- Summary