BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Peripheral Intravascular Lithotripsy (IVL) System

    Reg #: 3015053858 · FEI: 3015053858 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    SHOCKWAVE MEDICAL, INC.
    Registration Number
    3015053858
    FEI Number
    3015053858
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5403 Betsy Ross Drive
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180958

    Owner / Operator

    Firm Name
    Shockwave Medical, Inc.
    Operator Number
    10046972
    Address
    5403 Betsy Ross Drive
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Peter Nowakowski

    Products

    Device Name Product Code
    Percutaneous Catheter, Ultrasound PPN

    Proprietary Names

    Peripheral Intravascular Lithotripsy (IVL) System Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable Shockwave S4 Intravascular Lithotripsy (IVL) Catheter Shockwave M5 Intravascular Lithotripsy (IVL) Catheter Shockwave Medical Peripheral Lithoplasty System Lithoplasty Peripheral Balloon Dilatation Catheter

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device