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

    OSPREY Closed IV Catheter System (OspreyV2)

    K Number: K231626 · Decision Aug 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    OSPREY Closed IV Catheter System (OspreyV2)
    K Number
    K231626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skydance Vascular, Inc.
    Date Received
    June 2, 2023
    Decision Date
    August 31, 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 Skydance Vascular, Inc.

    K Number Device Name
    K250292 OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
    K223018 OSPREY PERIPHERAL IV Catheter System