BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C2 CryoBalloon Focal Catheter

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PENTAX of America, Inc.
    Registration Number
    2518897
    FEI Number
    1000080301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Paragon Drive
    City
    MONTVALE
    State
    NJ
    ZIP
    07645
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161202

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Gurvinder Nanda

    Products

    Device Name Product Code
    Unit, Cryosurgical, Accessories GEH

    Proprietary Names

    C2 CryoBalloon Focal Catheter C2 CryoAblation Cartridge, Regular C2 CryoAblation Cartridge, Large C2 CyroAblation Full Catheter C2 CryoAbation Swipe Catheter C2 CryoAblation Controller

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198