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

    REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM

    K Number: K123803 · Decision Jul 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    10
    Review Days
    204

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    Basic Information

    Device Name
    REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
    K Number
    K123803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reverse Medical Corporation
    Date Received
    December 10, 2012
    Decision Date
    July 2, 2013
    Product Code
    KRD
    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
    KRD Device, Vascular, For Promoting Embolization

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    Other Clearances by Reverse Medical Corporation

    K Number Device Name
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    K141313 REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
    K133282 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
    K130858 REVERSE MEDICAL MICROCATHETER
    K122684 REVERSE MEDICAL MICROCATHETER
    K112262 REFLEX BALLON GUIDE CATHETER
    K102418 REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
    K110055 REVERSE MEDICAL REFLEX GUIDE CATHETER
    K091563 RECRUIT MICROCATHETER