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

    AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE

    K Number: K973760 · Decision Feb 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    9
    Review Days
    139

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    Basic Information

    Device Name
    AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
    K Number
    K973760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avecor Cardiovascular, Inc.
    Date Received
    October 2, 1997
    Decision Date
    February 18, 1998
    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 Avecor Cardiovascular, Inc.

    K Number Device Name
    K964017 AFFINITY BLOOD PUMP SYSTEM
    K971105 MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
    K952532 AFFINITY ARTERIAL BLOOD FILTER
    K940126 AVECOR PRE-BYPASS FILTER
    K936003 AFFINITY CVR
    K935717 AFFINITY VENOUS RESERVIOR BAG
    K932252 AFFINITY HOLLOW FIBER OXYGENATOR
    K924529 SIGNATURE(TM) CUSTOM TUBING PACK