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

    TARGET VITAL-PORT VASCULAR ACCESS SYSTEM

    K Number: K970442 · Decision Apr 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    26
    Review Days
    84

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    Basic Information

    Device Name
    TARGET VITAL-PORT VASCULAR ACCESS SYSTEM
    K Number
    K970442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Med Institute, Inc.
    Date Received
    February 5, 1997
    Decision Date
    April 30, 1997
    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 Med Institute, Inc.

    K Number Device Name
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    K964001 SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
    K971140 VITAL-PORT INFUSION PAL
    K945586 FLEXIBLE DILATING SHEATH
    K960698 NON-CORING NEEDLE
    K941228 ENDOLUMINAL ACCESS TUBE
    K951077 VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM
    K951076 VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM
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