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
- K232788INSPIRA ART1002Cleared 510(K)
- K230698Anivia SG1000 Pump Console2Cleared 510(K)
- K221491Anivia SG1000 Pump Console2Cleared 510(K)
- K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure2Cleared 510(K)
- K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit2Cleared 510(K)
- K191557CentriMag Acute Circulatory Support System2Cleared 510(K)
- K131964BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE2Cleared 510(K)
- K131179CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR2Cleared 510(K)
- K112225SORIN CENTRIFUGAL PUMP 5 (CP5)2Cleared 510(K)
- K103468STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)2Cleared 510(K)
- K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR2Cleared 510(K)
- K093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES2Cleared 510(K)
- K091008STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-552Cleared 510(K)
- K090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES2Cleared 510(K)
- K083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE2Cleared 510(K)
- K081221LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE2Cleared 510(K)
- K080824BIO-CONSOLE 5602Cleared 510(K)
- K070286BIO-CONSOLE, MODEL 5602Cleared 510(K)
- K061369TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-85002Cleared 510(K)
- K053630LEVITRONIX CENTRIMAG PRIMARY CONSOLE2Cleared 510(K)
- K051303BIO-CONSOLE, MODEL 5602Cleared 510(K)
- K042374STOCKERT SCP RHYTHM2Cleared 510(K)
- K032213STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP2Cleared 510(K)
- K011838CENTRIFUGAL PUMP2Cleared 510(K)
- K971421BARD ISOFLOW BLOOD PUMP2Cleared 510(K)
- K9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM2Cleared 510(K)
- K936091MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER2Cleared 510(K)
- K941921BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 5502Cleared 510(K)
- K926357MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 1502Cleared 510(K)
- K924206MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E2Cleared 510(K)
- K924205MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 5502Cleared 510(K)
- K914754MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D2Cleared 510(K)
- K901584BIO-MEDICUS BIO CONSOLE MODELS 540 A B C2Cleared 510(K)
- K854133BIO MEDICUS BIO CONSOLE 5402Cleared 510(K)
- K853126BIO PACK MODEL 2002Cleared 510(K)
- K842503GAMBRO PULSATILE MONITOR PLM 10-2002Cleared 510(K)
- K780952MODEL 1812 CONTROL CONSOLE, ACCESSORIEX2Cleared 510(K)
- 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
- 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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TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K061369
- 510(k) Type
- Special
- Applicant
- CARDIAC ASSIST, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/22/2006
- Days to Decision
- 97 days
- Submission Type
- Summary