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

    Shockwave Medical Intravascular Lithotripsy (IVL) System

    K Number: K180454 · Decision Jun 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    12
    Review Days
    127

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    Basic Information

    Device Name
    Shockwave Medical Intravascular Lithotripsy (IVL) System
    K Number
    K180454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shockwave Medical, Inc.
    Date Received
    February 20, 2018
    Decision Date
    June 27, 2018
    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

    Similar 510(k) Clearances

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

    Bolt Intravascular Lithotripsy (IVL) System

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    Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter

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    Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

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    Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

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    FDA Class 2 ·Cardiovascular

    Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

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    FDA Class 2 ·Cardiovascular

    Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

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    View all

    Other Clearances by Shockwave Medical, Inc.

    K Number Device Name
    K243757 Shockwave CS Guide Catheter
    K242213 Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
    K240954 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
    K240225 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
    K221852 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
    K221041 Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
    K203365 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
    K191840 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
    K180958 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
    K163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
    Search all 12 clearances from Shockwave Medical, Inc. →