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

    NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET

    K Number: K971582 · Decision Dec 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    27
    Review Days
    236

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    Basic Information

    Device Name
    NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET
    K Number
    K971582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nipro Medical Corp.
    Date Received
    April 30, 1997
    Decision Date
    December 22, 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 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. →