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

    MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE

    K Number: K013556 · Decision Dec 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    14
    Review Days
    67

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    Basic Information

    Device Name
    MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
    K Number
    K013556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyco Healthcare
    Date Received
    October 25, 2001
    Decision Date
    December 31, 2001
    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 Tyco Healthcare

    K Number Device Name
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    K070653 KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
    K061492 MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
    K042709 DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
    K040897 DOVER ROB-NEL CATHETER
    K040649 KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
    K041243 DOVER RED RUBBER ROBINSON CATHETER
    K032438 MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
    K033453 KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
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