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

    GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

    K Number: K963368 · Decision Oct 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    5
    Review Days
    430

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    Basic Information

    Device Name
    GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE
    K Number
    K963368
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glycar, Inc.
    Date Received
    August 27, 1996
    Decision Date
    October 31, 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 Glycar, Inc.

    K Number Device Name
    K963967 GLYCAR PERICARDIAL PATCH
    K963175 GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
    K954665 GLYCAR STAPLE STRIPS
    K942911 GLYCAR TISSUE REPAIR PATCH