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

    REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM

    K Number: K133282 · Decision Nov 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    10
    Review Days
    33

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    Basic Information

    Device Name
    REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
    K Number
    K133282
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reverse Medical Corporation
    Date Received
    October 25, 2013
    Decision Date
    November 27, 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

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    K123803 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
    K122684 REVERSE MEDICAL MICROCATHETER
    K112262 REFLEX BALLON GUIDE CATHETER
    K102418 REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
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    K091563 RECRUIT MICROCATHETER