BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

    Reg #: 3022054170 · FEI: 3022054170 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SKYDANCE VASCULAR, INC.
    Registration Number
    3022054170
    FEI Number
    3022054170
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3058 Millcreek Rd.
    City
    Pleasant Grove
    State
    UT
    ZIP
    84062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250292

    Owner / Operator

    Firm Name
    SkyDance Vascular, Inc.
    Operator Number
    10087996
    Address
    3058 Millcreek Rd.
    City
    Pleasant Grove
    State
    UT
    Postal Code
    84062
    Country
    US
    Correspondent
    Scott J Pease

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

    Proprietary Names

    OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility