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

    VASCU-GUARD Peripheral Vascular Patch

    K Number: K142461 · Decision Nov 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    9
    Review Days
    84

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    Basic Information

    Device Name
    VASCU-GUARD Peripheral Vascular Patch
    K Number
    K142461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synovis Life Technologies, Inc.
    Date Received
    September 2, 2014
    Decision Date
    November 25, 2014
    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 Life Technologies, Inc.

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    K143589 GEM Flow COUPLER Device and System
    K142447 PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
    K142309 GEM Flow COUPLER Device and System
    K132727 GEM FLOW COUPLER DEVICE AND SYSTEM
    K130896 VASCULAR PROBE, VASCULAR PROBE ES