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

    TRANS-CATHETER EXTRACTOR

    K Number: K063048 · Decision Sep 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    345

    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
    TRANS-CATHETER EXTRACTOR
    K Number
    K063048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tran Pa-C, Inc.
    Date Received
    October 4, 2006
    Decision Date
    September 14, 2007
    Product Code
    ODY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ODY Tunneled Catheter Remover

    Similar 510(k) Clearances

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

    14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all