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

    SHELHIGH BIORING

    K Number: K023940 · Decision Jun 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    74
    Applicant Total
    8
    Review Days
    190

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    Basic Information

    Device Name
    SHELHIGH BIORING
    K Number
    K023940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shelhigh, Inc.
    Date Received
    November 26, 2002
    Decision Date
    June 4, 2003
    Product Code
    KRH
    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
    KRH Ring, Annuloplasty

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    Other Clearances by Shelhigh, Inc.

    K Number Device Name
    K032893 SHELHIGH NO-REACT BIOCUFF
    K982101 SHELHIGH NO-REACT DURA SHIELD
    K991567 SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
    K982810 SHELHIGH NO-REACT VASCUPATCH
    K981756 SHELHIGH NO-REACT PNEUMOPLEDGETS
    K974914 SHELHIGH NO-REACT PERICARDIAL PATCHES
    K964467 SHELHIGH PERICARDIAL PATCH