BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Chord-X Pre-measured Loops for Mitral Chordal Replacement

    Reg #: 1649833 · FEI: 3001584317 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    On-X Life Technologies Inc.
    Registration Number
    1649833
    FEI Number
    3001584317
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1300 East anderson Lane, Building B
    City
    Austin
    State
    TX
    ZIP
    78752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141060

    Owner / Operator

    Firm Name
    On-X Life Technologies, Inc
    Operator Number
    10022596
    Address
    1300 E. Anderson Lane, Bldg. B
    City
    Austin
    State
    TX
    Postal Code
    78752
    Country
    US

    Products

    Device Name Product Code
    Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement PAW

    Proprietary Names

    Chord-X Pre-measured Loops for Mitral Chordal Replacement

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility