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

    MEDRAD Imaging Bulk Package Transfer Spike

    K Number: K200280 · Decision Jul 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    10
    Review Days
    177

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    Basic Information

    Device Name
    MEDRAD Imaging Bulk Package Transfer Spike
    K Number
    K200280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Medical Care, Inc.
    Date Received
    February 4, 2020
    Decision Date
    July 30, 2020
    Product Code
    PQH
    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
    PQH Iodinated Contrast Media Transfer Tubing Set

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    Other Clearances by Bayer Medical Care, Inc.

    K Number Device Name
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    K250893 Ball Joint Guide Array (66295)
    K192370 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
    K193028 MEDRAD Mark 7 Arterion Injection System
    K182276 MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
    K182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
    K173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
    K143538 MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit