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

    SYNOVIS COLLAGEN MATRIX (TBD)

    K Number: K122306 · Decision Mar 8, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    8
    Review Days
    219

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    Basic Information

    Device Name
    SYNOVIS COLLAGEN MATRIX (TBD)
    K Number
    K122306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synovis Surgical Innovations
    Date Received
    August 1, 2012
    Decision Date
    March 8, 2013
    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 Synovis Surgical Innovations

    K Number Device Name
    K083039 VERITAS COLLAGEN MATRIX (DRY)
    K062915 VERITAS COLLAGEN MATRIX
    K041669 VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
    K040415 PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
    K040119 PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
    K040001 STEERABLE STYLET
    K030879 VERITAS COLLAGEN MATRIX