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
- 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
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Controller, Temperature, Cardiopulmonary Bypass
- Page Type
- Product Code
- Definition
- If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
- Regulation Medical Specialty
- Cardiovascular
- Review Panel
- Cardiovascular
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 870.4250
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- Yes
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 870.4250 Cardiopulmonary bypass temperature controller
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a) Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.
(b) Classification. Class II (performance standards).