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

    SHELHIGH PERICARDIAL PATCH

    K Number: K964467 · Decision Sep 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    8
    Review Days
    320

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    Basic Information

    Device Name
    SHELHIGH PERICARDIAL PATCH
    K Number
    K964467
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shelhigh, Inc.
    Date Received
    November 7, 1996
    Decision Date
    September 23, 1997
    Product Code
    DXZ
    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
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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    Other Clearances by Shelhigh, Inc.

    K Number Device Name
    K032893 SHELHIGH NO-REACT BIOCUFF
    K023940 SHELHIGH BIORING
    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