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

    speX LP Support Catheter

    K Number: K200094 · Decision Mar 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    10
    Review Days
    62

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    Basic Information

    Device Name
    speX LP Support Catheter
    K Number
    K200094
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reflow Medical
    Date Received
    January 16, 2020
    Decision Date
    March 18, 2020
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Reflow Medical

    K Number Device Name
    K210188 coraCross
    K193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35
    K193012 speX Support Catheter
    K151880 Wingman Crossing Catheter
    K141649 SPEX SUPPORT CATHETER
    K141547 WINGMAN EXTENDABLE TIP SUPPORT CATHETER
    K132420 WINGMAN EXTENDABLE TIP SUPPORT CATHETER
    K120178 WINGMAN EXTENDABLE TIP SUPPORT CATHETER
    K101479 WINGMAN EXTENDABLE TIP SUPPORT CATHETER