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

    VANISHPOINT I.V. CATHETER

    K Number: K051355 · Decision Sep 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    13
    Review Days
    122

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    Basic Information

    Device Name
    VANISHPOINT I.V. CATHETER
    K Number
    K051355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Retractable Technologies, Inc.
    Date Received
    May 24, 2005
    Decision Date
    September 23, 2005
    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 Retractable Technologies, Inc.

    K Number Device Name
    K202325 EasyPoint Blood Collection Plus
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    K122355 VANISHPOINT BLOOD COLLECTION SET
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    K101708 PATIENT SAFE LUER CAP
    K081420 VANISHPOINT I.V. CATHETER
    K072654 PATIENT SAFE SYRINGE
    K980069 VANISHPOINT SYRINGE
    K973301 ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
    K971763 BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
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