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

    OXYGENATOR MODEL NO. BENTLEY-10 PLUS

    K Number: K863249 · Decision Oct 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    59
    Review Days
    59

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    Basic Information

    Device Name
    OXYGENATOR MODEL NO. BENTLEY-10 PLUS
    K Number
    K863249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Bentley
    Date Received
    August 22, 1986
    Decision Date
    October 20, 1986
    Product Code
    DTZ
    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
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by American Bentley

    K Number Device Name
    K872896 UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
    K873923 INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
    K872167 CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
    K870804 CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
    K872133 OXYGENATOR MODEL NO. BENTLEY 5 PLUS
    K870911 INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
    K870269 ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100
    K861641 HEPARIN-COATED EXTRACORPOREAL CIRCUITS
    K862549 ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
    K860673 OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
    Search all 59 clearances from American Bentley →