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

    VITAACCESS (TM) CATHETER INTRODUCER SYSTEM

    K Number: K872998 · Decision Mar 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    13
    Review Days
    234

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    Basic Information

    Device Name
    VITAACCESS (TM) CATHETER INTRODUCER SYSTEM
    K Number
    K872998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Vitaphore Corp.
    Date Received
    August 3, 1987
    Decision Date
    March 24, 1988
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Vitaphore Corp.

    K Number Device Name
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    K891993 COLLAGEN NEUROSPONGE
    K896455 VITACHOICE WOUND DRESSING
    K896046 VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
    K895993 VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE
    K890435 VITAACCESS CATHETER INTRODUCER KIT
    K882100 VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT
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