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

    NIPRO SAFELET CATH

    K Number: K894371 · Decision Oct 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    9
    Review Days
    100

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    Basic Information

    Device Name
    NIPRO SAFELET CATH
    K Number
    K894371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pharma-Plast USA, Inc.
    Date Received
    July 17, 1989
    Decision Date
    October 25, 1989
    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 Pharma-Plast USA, Inc.

    K Number Device Name
    K894373 NIPRO DENTAL NEEDLE
    K894374 BLOOD DRAWING NEEDLE
    K894372 NIPRO NEEDLE HOLDER
    K884978 PHARMA-PLAST INSULIN INFUSION SET
    K871263 MULTIPLE PHARMA-PLAST TRACHEAL TUBE
    K852444 ASIK 'ONCE' SYRINGE
    K852443 PHARMA-PLAST CLINIPAK
    K852442 PHARMA-PLAST NEEDLE