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

    CRYOVALVE SG PULMONARY VALVE AND CONDUIT

    K Number: K083106 · Decision Feb 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    12
    Review Days
    109

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    Basic Information

    Device Name
    CRYOVALVE SG PULMONARY VALVE AND CONDUIT
    K Number
    K083106
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryolife, Inc.
    Date Received
    October 20, 2008
    Decision Date
    February 6, 2009
    Product Code
    OHA
    Advisory Committee
    Unknown
    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
    OHA Heart Valve, More Than Minimally Manipulated Allograft

    Similar 510(k) Clearances

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    CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

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    CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)

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    FDA Unclassified ·Unknown

    HUMAN HEART VALVE, CRYOVALVE SG

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    FDA Unclassified ·Unknown
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    Other Clearances by Cryolife, Inc.

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    K183635 PhotoFix Decellularized Bovine Pericardium
    K172085 PhotoFix Decellularized Bovine Pericardium
    K162506 PhotoFix Decellularized Bovine Pericardium
    K132105 PERCLOT TOPICAL
    K110581 PROPATCH SOFT TISSUE REPAIR MATRIX
    K101587 PROPATCH SOFT TISSUE REPAIR MATRIX
    K101866 CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
    K092021 CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
    K091626 CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
    K033484 HUMAN HEART VALVE, CRYOVALVE SG
    Search all 12 clearances from Cryolife, Inc. →