BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AC3 Series Intra-Aortic Balloon Pump (IABP)

    Reg #: 3013162291 · FEI: 3013162291 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Arrow International LLC (subsidiary of Teleflex Incorporated)
    Registration Number
    3013162291
    FEI Number
    3013162291
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192238

    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

    AC3 Series Intra-Aortic Balloon Pump (IABP)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility