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

    HydroMID 4F Single Lumen Midline Catheter

    K Number: K220772 · Decision Dec 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    212
    Registration Numbers
    213
    Same Product Code
    496
    Applicant Total
    4
    Review Days
    266

    Basic Information

    Device Name
    HydroMID 4F Single Lumen Midline Catheter
    K Number
    K220772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Access Vascular, Inc.
    Date Received
    March 16, 2022
    Decision Date
    December 7, 2022
    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 Access Vascular, Inc.

    K Number Device Name
    K251212 Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
    K244059 HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)
    K243941 HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)