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
- K232291Essenz HLM, Essenz ILBM2Cleared 510(K)
- K221895Terumo Advanced Perfusion System 12Cleared 510(K)
- K221373Essenz HLM2Cleared 510(K)
- K210130Stockert S5 System2Cleared 510(K)
- K202125Century Perfusion System2Cleared 510(K)
- K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)2Cleared 510(K)
- K173834Quantum Pump Console2Cleared 510(K)
- K172220Advanced Perfusion System 12Cleared 510(K)
- K163531Advanced Perfusion System 12Cleared 510(K)
- K153376Advanced Perfusion System 12Cleared 510(K)
- K151349Advanced Perfusion System 12Cleared 510(K)
- K133598CARDIOHELP SYSTEM2Cleared 510(K)
- K131041ADVANCED PERFUSION SYSTEM 12Cleared 510(K)
- K102726CARDIOHELP SYSTEM2Cleared 510(K)
- K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE2Cleared 510(K)
- K093882SORIN C5 SYSTEM MODEL 58-00-002Cleared 510(K)
- K092463SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM2Cleared 510(K)
- K090006LIFEBRIDGE B2T, MODEL 70012Cleared 510(K)
- K091007AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-052Cleared 510(K)
- K080832STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER2Cleared 510(K)
- K071318MODIFICATION TO: STOCKERT S5 SYSTEM2Cleared 510(K)
- K070213PERFORMER CBP SYSTEM2Cleared 510(K)
- K062396MODIFICATION TO STOCKERT S5 SYSTEM2Cleared 510(K)
- K060053STOCKERT S5 SYSTEM2Cleared 510(K)
- K052555MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB2Cleared 510(K)
- K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH2Cleared 510(K)
- K030141MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-1002Cleared 510(K)
- K021694CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-1002Cleared 510(K)
- K020571STOCKERT CENTRIFUGAL PUMP CONSOLE2Cleared 510(K)
- K011088SIII ALARM AMPLIFIER2Cleared 510(K)
- K002118STOCKERT COMPACT SYSTEM VERSION 2.02Cleared 510(K)
- K002116S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.02Cleared 510(K)
- K982014STOCKERT COMPACT SYSTEM2Cleared 510(K)
- K964017AFFINITY BLOOD PUMP SYSTEM2Cleared 510(K)
- K943803JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM2Cleared 510(K)
- K950990STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE2Cleared 510(K)
- K942582SORIN BLOOD CARDIOPLEGIA CONSOLE2Cleared 510(K)
- K915183SARNS 8000 MODULAR PERFUSION SYSTEM2Cleared 510(K)
- K871131SARNS 9000 HEART-LUNG CONSOLE2Cleared 510(K)
- K870976ONGUARD 1000, CATALOG #043611-000 & 043611-0012Cleared 510(K)
- K863960STOCKERT-SHILEY CAPS BATTERY MODULE2Cleared 510(K)
- K863541STOCKERT-SHILEY CAPS HLM INTERFACE2Cleared 510(K)
- K862973STOCKERT-SHILEY CAPS TIMER MODULE2Cleared 510(K)
- K861388SARNS PORTABLE POWER MODULE2Cleared 510(K)
- K851614CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY2Cleared 510(K)
- K851615CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE2Cleared 510(K)
- K842138COBE EMERGENCY POWER SOURCE 43610-0002Cleared 510(K)
- K822068GAMBRO PUMP CONSOLE CSL2Cleared 510(K)
- K813034POLYSTAN HEART LUNG MACHINE SYS2Cleared 510(K)
- K801097SARNS 7000 MONITOR MODULE2Cleared 510(K)
- K772001SARNES HELP2Cleared 510(K)
- K770002CONSOLE, MOBILE FOR 3 PUMPS W/MASTS2Cleared 510(K)
- 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
- 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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- OphthalmicReview Panel
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- UnknownReview Panel
AFFINITY BLOOD PUMP SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K964017
- 510(k) Type
- Traditional
- Applicant
- AVECOR CARDIOVASCULAR, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/5/1997
- Days to Decision
- 302 days
- Submission Type
- Summary