BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    R2P Metacross RX

    K Number: K163479 · Decision Jan 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    10
    Review Days
    30

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    Basic Information

    Device Name
    R2P Metacross RX
    K Number
    K163479
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KANEKA Corporation
    Date Received
    December 12, 2016
    Decision Date
    January 11, 2017
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by KANEKA Corporation

    K Number Device Name
    K172264 OTW Takeru PTCA Balloon Dilatation Catheter
    K170941 RX NC Takeru PTCA Balloon Dilatation Catheter
    K163372 RX Takeru Balloon Dilatation Catheter
    K160004 Crosstella OTW
    K160013 Crosperio OTW
    K152887 Crosperio RX PTA Balloon Dilatation Catheter
    K152873 Crosstella RX Balloon Dilatation Catheter
    K152080 Metacross OTW PTA Balloon Dilatation Catheter
    K150865 Metacross RX PTA Balloon Dilitation Catheter