BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AutoCAT2WAVE® Intra-Aortic Balloon Pump,

    Reg #: 3010532612 · FEI: 3010532612 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Arrow International, LLC (subsidiary of Teleflex, Incorporated)
    Registration Number
    3010532612
    FEI Number
    3010532612
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    16 Elizabeth Dr
    City
    Chelmsford
    State
    MA
    ZIP
    01824
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060309

    Owner / Operator

    Firm Name
    Arrow International LLC (subsidiary of Teleflex Incorporated
    Operator Number
    2518433
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    Products

    Device Name Product Code
    System, Balloon, Intra-Aortic And Control DSP

    Proprietary Names

    AutoCAT2WAVE® Intra-Aortic Balloon Pump, AutoCAT®2 Intra-Aortic Balloon System AutoCAT®2 Intra-Aortic Balloon Pump, AutoCAT2WAVE® Intra-Aortic Balloon System AUTOPILOT®

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device