BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SARNS WARMER, PART #164975 AND #164980

    K Number: K873813 · Decision Nov 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    76
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SARNS WARMER, PART #164975 AND #164980
    K Number
    K873813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    September 18, 1987
    Decision Date
    November 6, 1987
    Product Code
    DWC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWC Controller, Temperature, Cardiopulmonary Bypass

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DWC), ordered by most recent decision date.

    Heater-Cooler System 3T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Heater-Cooler

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Heater-Cooler System 3T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SORIN FLEXTHERM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEATER-COOLER UNIT HCU 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by 3M Health Care, Sarns

    K Number Device Name
    K960916 SAMS 8000 CARDIOPLEGIA MONITOR
    K953901 SARNS 800 ROLLER PUMP
    K950739 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
    K941653 SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION
    K941654 SARNS FILTERED VENOUS RESERVIOR MODIFICATION
    K940651 SARNS ULTRASONIC AIR SENSOR
    K935391 SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
    K934127 SARNS LOW JETTING AORTIC ARCH CANNULA
    K935977 SARNS AIR DETECTION SYSTEM
    K915547 SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
    Search all 76 clearances from 3M Health Care, Sarns →