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

    SAFEWEDGE(TM) RELIEF VALVE DEVICE

    K Number: K912172 · Decision Sep 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    7
    Review Days
    134

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    Basic Information

    Device Name
    SAFEWEDGE(TM) RELIEF VALVE DEVICE
    K Number
    K912172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sunscope Intl., Inc.
    Date Received
    May 16, 1991
    Decision Date
    September 27, 1991
    Product Code
    KRB
    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
    KRB Probe, Thermodilution

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    K973477 BIOSENSORS EMBOLECTOMY CATHETER
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    K911710 HEPARIN COATED THERMODILUTION CATH & ACCESSORIES