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

    STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM

    K Number: K951875 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    11
    Review Days
    33

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    Basic Information

    Device Name
    STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM
    K Number
    K951875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Strato/Infusaid, Inc.
    Date Received
    April 21, 1995
    Decision Date
    May 24, 1995
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Strato/Infusaid, Inc.

    K Number Device Name
    K960391 STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
    K953529 STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
    K954720 STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS
    K953254 STRATO/INFUSAID INFUSE-A-KIT
    K953256 STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS
    K953436 STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM
    K950987 STRATO/INFUSAID TUNNELER
    K951874 STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM
    K951873 STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM
    K951872 STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM
    Search all 11 clearances from Strato/Infusaid, Inc. →