BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter

    Reg #: 1000563940 · FEI: 1000563940 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Arrow International CR, a.s.
    Registration Number
    1000563940
    FEI Number
    1000563940
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PRAZSKA 209
    City
    Hradec Kralove
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K140110

    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

    US Agent

    Business Name
    Teleflex, Inc.
    Contact Name
    Divya Raman
    Address
    3015 Carrington Mill Boulevard
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    612 4231738

    Products

    Device Name Product Code
    Catheter, Conduction, Anesthetic BSO

    Proprietary Names

    Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus Combined Spinal Epidural Catheterization Kit FlexTip Plus Epidural Catheterization Kit

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device