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

    STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS

    K Number: K946250 · Decision May 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    45
    Review Days
    130

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    Basic Information

    Device Name
    STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
    K Number
    K946250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Strato Medical Corp.
    Date Received
    December 23, 1994
    Decision Date
    May 2, 1995
    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 Strato Medical Corp.

    K Number Device Name
    K945956 STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
    K942848 STRATO MEDICAL LIFEPORT LPS 7515
    K934518 STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM
    K932509 STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT
    K933884 STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM
    K924851 STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
    K924677 STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH
    K921751 INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER
    K915273 LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555
    K924505 SNAP-LOCK MICROPORT - REVISED
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