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

    RA-308 Excimer Laser System, Excimer Laser Catheter

    K Number: K170349 · Decision May 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    56
    Applicant Total
    4
    Review Days
    110

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RA-308 Excimer Laser System, Excimer Laser Catheter
    K Number
    K170349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ra Medical Systems,Inc
    Date Received
    February 3, 2017
    Decision Date
    May 24, 2017
    Product Code
    PDU
    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
    PDU Catheter For Crossing Total Occlusions

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PDU), ordered by most recent decision date.

    Santreva™-ATK Endovascular Revasculariztion Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PowerWire® 14 Radiofrequency Guidewire Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LimFlow ARC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PowerWire Radiofrequency Guidewire Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SoundBite® Crossing System XS Peripheral

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tigereye ST CTO-Crossing Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Ra Medical Systems,Inc

    K Number Device Name
    K220544 DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
    K210664 DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
    K062963 PHAROS EXCIMER LASER SYSTEM, MODEL EX-308