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

    MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652

    K Number: K961336 · Decision Jul 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    14
    Review Days
    101

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    Basic Information

    Device Name
    MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652
    K Number
    K961336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic PS Medical
    Date Received
    April 8, 1996
    Decision Date
    July 18, 1996
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Medtronic PS Medical

    K Number Device Name
    K012052 MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
    K010361 MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
    K010487 BIPOLAR PENCIL, MODEL 3901-002, 3900-002
    K010341 MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
    K003914 MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
    K002572 MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
    K991502 MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
    K990333 MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
    K984053 BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
    K983799 MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
    Search all 14 clearances from Medtronic PS Medical →