BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KELLY-WICK TANNELER

    K Number: K830471 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    313
    Registration Numbers
    313
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    37

    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
    KELLY-WICK TANNELER
    K Number
    K830471
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Prosthetics Research
    Date Received
    February 15, 1983
    Decision Date
    March 24, 1983
    Product Code
    DWS
    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
    DWS Instruments, Surgical, Cardiovascular

    Similar 510(k) Clearances

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

    MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    G.E. STERILE ANGIOGRAPHIC TRAY

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    G.E. STERILE CT BIOPSY TRAY

    FDA 510(k)
    FDA Class 1 ·Cardiovascular
    View all