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

    NIPRO BIO-FLEX CATHETER

    K Number: K022756 · Decision Oct 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    27
    Review Days
    59

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    Basic Information

    Device Name
    NIPRO BIO-FLEX CATHETER
    K Number
    K022756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nipro Medical Corp.
    Date Received
    August 20, 2002
    Decision Date
    October 18, 2002
    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 Nipro Medical Corp.

    K Number Device Name
    K093985 NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
    K081210 NIPRO SAFETOUCH HUBER INFUSTION SET
    K072024 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
    K063368 NIPRO BIOHOLE NEEDLE
    K063721 NIPRO SAFETOUCH II GAMMA
    K052474 NIPRO HYPODERMIC NEEDLE
    K051574 NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
    K041779 NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
    K032777 MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
    K030683 NIPRO DISPOSABLE SYRINGES
    Search all 27 clearances from Nipro Medical Corp. →