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

    MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT

    K Number: K970341 · Decision Apr 23, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    14
    Review Days
    84

    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
    MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT
    K Number
    K970341
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic PS Medical
    Date Received
    January 29, 1997
    Decision Date
    April 23, 1997
    Product Code
    LIS
    Advisory Committee
    Unknown
    Review Advisory Committee
    HO
    Third Party
    N

    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 →