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

    PARADIGM QUICK-SET INFUSION SET

    K Number: K011071 · Decision Jun 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    9
    Review Days
    59

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    Basic Information

    Device Name
    PARADIGM QUICK-SET INFUSION SET
    K Number
    K011071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maersk Medical A/S
    Date Received
    April 9, 2001
    Decision Date
    June 7, 2001
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Maersk Medical A/S

    K Number Device Name
    K002138 PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
    K990112 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
    K990110 DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
    K990111 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
    K990115 DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
    K990113 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
    K991759 MAERSK MEDICAL CONTOUR INFUSION SET
    K973364 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG