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

    ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903

    K Number: K940079 · Decision Nov 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    110
    Review Days
    327

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    Basic Information

    Device Name
    ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
    K Number
    K940079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Arrow Intl., Inc.
    Date Received
    January 7, 1994
    Decision Date
    November 30, 1994
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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