BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arrow® Wedge Pressure Catheter,

    Reg #: 3015859709 · FEI: 3015859709 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Arrow International, LLC (subsidiary of Teleflex Incorporated)
    Registration Number
    3015859709
    FEI Number
    3015859709
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 Innovation Way
    City
    Wyomissing
    State
    PA
    ZIP
    19610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960479

    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
    Electrode, Pacemaker, Temporary LDF

    Proprietary Names

    Arrow® Wedge Pressure Catheter, Arrow® Temporary Pacing Catheters, Arrow® BiPolar Pacing Catheters

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility