BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Powerflex Extreme

    Reg #: 1016427 · FEI: 1016427 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Cordis US Corp.
    Registration Number
    1016427
    FEI Number
    1016427
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14201 N.W. 60TH AVE.
    City
    Miami Lakes
    State
    FL
    ZIP
    33014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032737

    Owner / Operator

    Firm Name
    Cordis US Corp.
    Operator Number
    1016427
    Address
    5452 Betsy Ross Drive, --
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Linda Ruedy

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    Powerflex Extreme Powerflex P3 Percutaneous Transluminal Angioplasty (PTA) Catheter OPTA Pro Percutaneous Transluminal Angioplasty (PTA) Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198