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

    Bolt Intravascular Lithotripsy (IVL) System

    K Number: K250225 · Decision Mar 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    Bolt Intravascular Lithotripsy (IVL) System
    K Number
    K250225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bolt Medical, Inc.
    Date Received
    January 27, 2025
    Decision Date
    March 25, 2025
    Product Code
    PPN
    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
    PPN Percutaneous Catheter, Ultrasound

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