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

    IN-TIME RETRIEVAL DEVICE

    K Number: K014109 · Decision Mar 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    31
    Applicant Total
    19
    Review Days
    88

    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
    IN-TIME RETRIEVAL DEVICE
    K Number
    K014109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific, Target
    Date Received
    December 14, 2001
    Decision Date
    March 12, 2002
    Product Code
    MMX
    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
    MMX Device, Percutaneous Retrieval

    Similar 510(k) Clearances

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

    LimFlow V-Ceiver

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amplatz Goose Neck Snare Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gunther Tulip Vena Cava Filter Retrieval Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LimFlow V-Ceiver

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONO Retrieval Device

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

    Other Clearances by Boston Scientific, Target

    K Number Device Name
    K031049 GUGLIELMI DETACHABLE COIL (GDC)
    K031168 MATRIX STRETCH RESISTANT DETACHABLE COIL
    K030475 GDC STRETCH RESISTANT DETACHABLE COIL
    K022860 ATLANTIS PV IMAGING CATHETER, MODEL 36456
    K022357 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
    K021494 GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
    K012985 MATRIX DETACHABLE COILS
    K013789 EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
    K010853 GUIDER SOFTIP GUIDING CATHETER XF 5F
    K010707 ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
    Search all 19 clearances from Boston Scientific, Target →