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

    MACROPORE CARDIO-WRAP (TS)

    K Number: K031785 · Decision Sep 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    17
    Review Days
    86

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    Basic Information

    Device Name
    MACROPORE CARDIO-WRAP (TS)
    K Number
    K031785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Macropore Biosurgery, Inc.
    Date Received
    June 10, 2003
    Decision Date
    September 4, 2003
    Product Code
    OMH
    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
    OMH Pericardial Patch To Facilitate Revision Surgeries

    Other Clearances by Macropore Biosurgery, Inc.

    K Number Device Name
    K042261 MACROPORE PURICEL LIPOPLASTY SYSTEM
    K041105 MACROPORE HYDROSORB SPINE SYSTEM
    K031955 MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
    K024169 MACROPORE OS RECONSTRUCTION
    K023643 MACROPORE SURGICAL BARRIER FILM
    K021164 MACROPORE OS TRAUMA
    K012025 MACROPORE SURGIWRAP (TS)
    K012769 MACROPORE ENT RECONSTRUCTION FILM
    K012413 MACROPORE FX, PS, NS, LP
    K011715 MACROPORE IB RESORBABLE PLUG
    Search all 17 clearances from Macropore Biosurgery, Inc. →