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

    The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

    K Number: K223788 · Decision Sep 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    9
    Review Days
    270

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    Basic Information

    Device Name
    The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
    K Number
    K223788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medsource International, LLC
    Date Received
    December 19, 2022
    Decision Date
    September 15, 2023
    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 Medsource International, LLC

    K Number Device Name
    K161779 MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
    K150333 MedSource Sharps Dart
    K140442 MEDSOURCE SELECTABLE IV SET
    K140402 MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
    K131555 MEDSOURCE IV SAFETY CATHETER
    K120424 MEDSOURCE IV ADMINSTRATION SET
    K080339 MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
    K081516 MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT