BEUDAMED
    Product Code: DWC FDA class 2 21 CFR 870.4250

    Controller, Temperature, Cardiopulmonary Bypass

    Cardiovascular

    The Cardiopulmonary Bypass Temperature Controller is a life-sustaining cardiovascular device used to regulate the temperature of water or blood within the heat-exchange system of an extracorporeal circuit, controlling patient body temperature during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWC and it is regulated under 21 CFR 870.4250 within the Cardiovascular medical specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission (82 FR 26807). This device is designated as life-sustaining or life-supporting.

    View on FDA
    510(k)s
    30
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    22
    Years Active
    42

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    Basic Information

    Product Code
    DWC
    Device Class
    FDA class 2
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 30 510(k) clearances via K numbers.

    K Number Device Name
    K220635 Heater-Cooler System 3T
    K212657 Quantum Heater-Cooler
    K191402 Heater-Cooler System 3T
    K140012 SORIN FLEXTHERM
    K130300 HEATER-COOLER UNIT HCU 40
    K122813 HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
    K102147 CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
    K071521 TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
    K052601 STOCKERT HEATER-COOLER SYSTEM 3T
    K031544 HEATER COOLER UNIT, MODEL HCU 30
    K014016 ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
    K003145 ORIGEN BLADDER HOLDER
    K001520 ALPHA OMEGA DUAL COOLER-HEATER
    K945720 JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
    K896975 CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
    K896974 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
    K896973 CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
    K896972 CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
    K896971 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
    K896393 CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
    K893940 POLYSTAN HEATER-COOLER UNIT
    K883603 SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
    K873924 PTI HEART-CHILL POUCH/PAD SLING (STERILE)
    K874927 PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
    K873699 ECMO-TEMP (TM) BLOOD WARMING DEVICE
    K873813 SARNS WARMER, PART #164975 AND #164980
    K841402 TEMPERATURE CONTROL & MONITOR
    K831677 HYPER-HYPOTHERMIA UNIT HYPO 10-200
    K822874 THERMOSTATIC WATER MIXING VALVE TWV10
    K810647 SHILEY OXYGENATOR THERMISTOR PROBE

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.