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

    ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975

    K Number: K010707 · Decision Mar 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    19
    Review Days
    20

    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
    ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
    K Number
    K010707
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific, Target
    Date Received
    March 9, 2001
    Decision Date
    March 29, 2001
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

    Similar 510(k) Clearances

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

    Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arterial Pressure Monitoring Set/Tray

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DualView Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    pNOVUS 21 Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Impress Angiographic Catheter

    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
    K014109 IN-TIME RETRIEVAL DEVICE
    K012985 MATRIX DETACHABLE COILS
    K013789 EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
    K010853 GUIDER SOFTIP GUIDING CATHETER XF 5F
    Search all 19 clearances from Boston Scientific, Target →