BEUDAMED
    FDA Registration Active 🇺🇸 United States

    pREBOA-PRO Catheter

    Reg #: 3026788751 · FEI: 3026788751 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Prytime Medical Devices, Inc.
    Registration Number
    3026788751
    FEI Number
    3026788751
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12 Upper Balcones Rd., Suite 300
    City
    Boerne
    State
    TX
    ZIP
    78006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200459

    Owner / Operator

    Firm Name
    Prytime Medical Devices, Inc.
    Operator Number
    10050783
    Address
    12 Upper Balcones Rd, Suite 300
    City
    Boerne
    State
    TX
    Postal Code
    78006
    Country
    US
    Correspondent
    Julie Burgett

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Percutaneous DQY
    Catheter, Intravascular Occluding, Temporary MJN

    Proprietary Names

    pREBOA-PRO Catheter

    Establishment Types

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