BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHORD-X EPTFE SUTURE

    K Number: K121173 · Decision Aug 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    121

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CHORD-X EPTFE SUTURE
    K Number
    K121173
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    On-Xlifetechnologies
    Date Received
    April 17, 2012
    Decision Date
    August 16, 2012
    Product Code
    PAW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PAW), ordered by most recent decision date.

    MitraPatch Mitral Valve Repair System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all