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
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE1Cleared 510(K)
- K992635INTERFACE MODULE IDDD1Cleared 510(K)
- K990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS1Cleared 510(K)
- K934782AMMEX TUBING ORGANIZER1Cleared 510(K)
- K926233CARDIO2 CYCLE1Cleared 510(K)
- K922404TUBE GRIP1Cleared 510(K)
- K892856NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS1Cleared 510(K)
- K884893CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-251Cleared 510(K)
- K884640CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 7001Cleared 510(K)
- K874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR1Cleared 510(K)
- K874925CPE 2000 CARDIO PULMONARY ERGOMETER1Cleared 510(K)
- K864890STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP1Cleared 510(K)
- K862510STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 11Cleared 510(K)
- K862549ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE1Cleared 510(K)
- K860298STABLELINE1Cleared 510(K)
- K860672ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL1Cleared 510(K)
- K854113CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH1Cleared 510(K)
- K852455GAMBRO DIGITAL TELETHERMOMETER TTH 10-2001Cleared 510(K)
- K851077CARDIAC COOLING JACKET1Cleared 510(K)
- K851289COBE GAS FILTER1Cleared 510(K)
- K841812HOLDER FOR BOS-10, 10S 5S1Cleared 510(K)
- K841296TUBE TENDER1Cleared 510(K)
- K841032HOLDER FOR MODELS AF-10,1025,1040,51Cleared 510(K)
- K832704SHILEY GAS FILTER1Cleared 510(K)
- K832411GASLINE FILTER #GF-101Cleared 510(K)
- K830167HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-1Cleared 510(K)
- K822097D645-BACTERIOLOGICAL GAS LINE FILTER1Cleared 510(K)
- K820406TMO INTEGRATED CIRCUIT SYSTEM1Cleared 510(K)
- K813271TEMPERATURE PROBES1Cleared 510(K)
- K811368CARDIOPLEGIA COOLING & ADMIN. SETS1Cleared 510(K)
- K811348CARDIOPULMONARY BYPASS ACCESSORY EQUIP.1Cleared 510(K)
- K810079SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS1Cleared 510(K)
- K802541DISPOSABLE PARALLEL Y CONNECTORS1Cleared 510(K)
- K802539DISPOSABLE GAS LINE FILTER1Cleared 510(K)
- K802542DISPOSABLE CONNECTORS1Cleared 510(K)
- K802906WILLIAM HARVEY OXYGENATING GAS FILTER1Cleared 510(K)
- K792151OXYGENATOR GAS LINE FILTER1Cleared 510(K)
- K791829SHILEY QUICK DISCONNECT ASSEMBLY1Cleared 510(K)
- K790192SARNO SINGLE POLE MAST1Cleared 510(K)
- K781861FILTER, EXTRACORPOREAL BLOOD HOLDER1Cleared 510(K)
- K780984PVC QUICK PRIME LINES1Cleared 510(K)
- K770681VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR1Cleared 510(K)
- 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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CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K854113
- 510(k) Type
- Traditional
- Applicant
- AMERICAN BENTLEY
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/8/1986
- Days to Decision
- 92 days