BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHOCKWAVE MEDICAL, INC.

    Reg #: 3015053858 · FEI: 3015053858 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    29
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    SHOCKWAVE MEDICAL, INC.
    Registration Number
    3015053858
    FEI Number
    3015053858
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5403 Betsy Ross Drive
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240954
    PMA Number
    P200039

    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
    Cardiovascular Procedure Kit OEZ
    Shockwave Intravascular Lithotripsy System QMG
    Catheter, Percutaneous DQY

    Proprietary Names

    Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave Medical, Inc. Peripheral Lithoplasty System Lithoplasty Peripheral Balloon Dilatation Catheter Shockwave S4 IVL Catheter Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System Shockwave M5 IVL Catheter Shockwave Medical Peripheral Lithoplasty System Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable Shockwave S4 Intravascular Lithotripsy (IVL) Catheter Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable Shockwave M5 Intravascular Lithotripsy (IVL) Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave S4 IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter Shockwave C2+ Shockwave C2 Aero Fly Coronary IVL Catheter Shockwave C2 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary IVL Catheter Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Shockwave C2 Catheter Shockwave C2 Aero Coronary IVL Catheter Shockwave Intravascular Lithotripsy System with Shockwave C2+ Coronary IVL Catheter Shockwave C2+ Coronary IVL Catheter Shockwave CS Guide Catheter Peripheral Intravascular Lithotripsy (IVL) System

    Establishment Types

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