BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter

    Reg #: 3006425876 · FEI: 3006425876 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Arrow International C.R. a.s.
    Registration Number
    3006425876
    FEI Number
    3006425876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JAMSKA 2359/47
    City
    ZDAR NAD SAZAVOU Vysocina
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K895417

    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, Subclavian LFJ

    Proprietary Names

    Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter Marked Spring-Wire Guide with Arrow Advancer Hemodialysis (Acute) Products

    Establishment Types

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