BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    SWAV CR SRL

    Reg #: 3027545377 · FEI: 3027545377 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    SWAV CR SRL
    Registration Number
    3027545377
    FEI Number
    3027545377
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Coyol Free Zone, Building B50.B., El Coyol
    City
    Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K240225
    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

    US Agent

    Business Name
    SHOCKWAVE MEDICAL, INC.
    Contact Name
    Peter Nowakowski
    Address
    5403 Betsy Ross Dr
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US
    Email
    [email protected]
    Phone
    408 5502609

    Products

    Device Name Product Code
    Percutaneous Catheter, Ultrasound PPN
    Shockwave Intravascular Lithotripsy System QMG

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device