BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    RediGuard® Intra-Aortic Balloon Catheter

    Reg #: 9680794 · FEI: 3003737899 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Arrow Internacional de Chihuahua S.A. de C.V.
    Registration Number
    9680794
    FEI Number
    3003737899
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ave. Washington 3701, Interior Circuito Industrial, Alta Tecnologia Edificios 2, 4, 36 and 40, Colonia Panamericana
    City
    CHIHUAHUA
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K021462

    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
    System, Balloon, Intra-Aortic And Control DSP

    Proprietary Names

    RediGuard® Intra-Aortic Balloon Catheter Intra-Aortic Balloon (IAB) Catheter AutoCAT®2 Series FIBEROPTIX® Intra-Aortic Balloon Catheter, Ultra 8® AutoCAT®2 Intra-Aortic Balloon Pump (IABP) Fiber Optic System (FOS) FiberOptix® IAB Catheter, AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP)

    Establishment Types

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