BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Arrow International CR, a.s.

    Reg #: 1000563940 · FEI: 1000563940 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    121
    Establishment Types
    4
    Classifications
    23

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    Registration Details

    Registration Name
    Arrow International CR, a.s.
    Registration Number
    1000563940
    FEI Number
    1000563940
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PRAZSKA 209
    City
    Hradec Kralove
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K962577

    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, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Anesthesia Conduction Kit CAZ
    Drape, Surgical, Antimicrobial KKX
    Catheter, Subclavian LFJ
    Introducer, Catheter DYB
    Catheter, Percutaneous DQY
    Catheter, Hemodialysis, Non-Implanted MPB
    Chest Drainage Kit PAD
    Wire, Guide, Catheter DQX
    Device, Intravascular Catheter Securement KMK
    Set, Administration, Intravascular FPA
    Stopcock, I.V. Set FMG
    Catheter, Irrigation GBX
    Catheter, Flow Directed DYG
    Catheter, Conduction, Anesthetic BSO
    Catheter, Hemodialysis, Triple Lumen, Non-Implanted NIE
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Instrument, Manual, Surgical, General Use MDM
    Accessories, Catheter KGZ
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Arrow GPSCath Balloon Dilatation Catheter Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter Ag+ Quad Lumen CVCs Arrow Continuous Nerve Block Needle Arrow Stimulator Adapter Cable Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile) Arrow StimuCath® Continuous Nerve Block Set Drape surgical Hemodialysis (Acute) Products Marked Spring-Wire Guide with Arrow Advancer Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter Transseptal Super ArrowFlex PSI Arrow® Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set Arrow Jugular Puncture Kit Single Lumen CVCs Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature Arrow TheraCath® Epidural Catheter Arrow Epidural Catheterization Kit with TheraCath® Catheter Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter, 14 Fr 2-L Hemodialysis Catheters You-Bend Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter Arrow Epidural Catheterization Kit/Set with FlexTip Plus® Catheter Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus® Epidural Catheterization Kit for Caudal Placement SnapLock™ Clamp Fastener Arrow® SnapLock™ Catheter/Syringe Adapter FlexTip Plus® Epidural Catheterization Kit FlexTip Plus® Combined Spinal Epidural Catheterizaiton Kit FlexTip Plus(R) Epidural Catheterization Kit for Lumbar Placement Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter M-L CVC w/BlueFlex Tip Arrow Pressure Injectable Central Venous Catheterization Kit Ag+ & Ag+BP Pressure Injectable CVC Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit Pneumothorax Set STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES ARROWg+ard Hemodialysis Catheters Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter Intravascular catheter securement Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter ARROWg+ard Blue Plus Multi-Lumen CVC Kit ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit ARROWg+ard Blue Plus Two-Lumen CVC Kit ARROWg+ard Blue Plus Two-Lumen CVC Super Kit ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit ARROWg+ard Blue Plus Multi-Lumen CVC Set ARROWg+ard Blue Plus Quad-Lumen CVC Super Kit AGB+ Two-Lumen CVC Kit AGB+ Multi-Lumen CVC Kit ARROWg+ard Blue Plus Quad-Lumen CVC Set ARROWg+ard Blue Plus Quad-Lumen CVC AGB+ Quad Lumen CVC Kit ARROWg+ard Blue Plus Two-Lumen CVC Set ARROWg+ard Blue Plus Two-Lumen CVC Ag+ Blue Plus ML CVCs Arrow® Arterial Catheterization Set Drape, Surgical Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device ARROWg+ard 2-L Access (MAC) INTERLINK(TM) INJECTION SITE Elcam Stopcock Percutaneous Cavity Drainage Catheterization Set/Kit PERCUTANEOUS CAVITY DRAI Arrow Seldinger Arterial Catheterization Device Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter ARROWg+ard CVCs Arrow® Thermodilution Catheters Infusion Port Thermodilution Antecubital Central Venous Catheterization Kit with Heparin-Coated Catheter Ag+ Super ArrowFlex PSIs Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath Arrow Radial Artery Arterial Catheter UltraCath Continuous Nerve Block Kit UltraCath Continuous Nerve Block Catheter ARROW® FlexBlock Continuous Peripheral Nerve Block Sets ARROW® FlexBlock Continuous Peripheral Nerve Block Kits ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheterization Kit FlexTip Plus Combined Spinal Epidural Catheterization Kit Spring Wire Guide Arrow PSI PERCUTANEOUS SHEATH INTRODUCER Arrow Epidural Needle NEW HYDROPHILIC COATING FOR WIRE GUIDES StimuCath PNB Catheter Arrow® Continuous Nerve Block Set Arrow® Continuous Nerve Block Kit Arrow Continuous Peripheral Nerve Block Kit Arrow Prep Tray Arrow Nerve Block Prep Tray Arrow Access Tray Arrow® Epidural Needle Arrow Epidural Anesthesia Kit Arrow® Continuous Epidural Needle Arrow Single Shot Epidural Anesthesia Kit Single Shot Epidural Anesthesia Kit FlexTip Plus & Accessories Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter Pediatric 2-L Hemodialysis Catheter EZ-BLOCKER StimuCath (19 Ga) SUR Betha Sheet Holder Multiple General Use Arrow FlexBlock Continous Peripheral Nerve Block Kits Arrow Catheter Clamp for 5, 6, 7 and 8 Fr. Catheters Large Bore Multi-Lumen CVCs Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter RA Catheter w/Integral Ndl Protect ARROW Radial Artery Catheterization Set with Integral Needle Protection Arrow® 10 mL Luer-Slip Loss of Resistance Syringe Arrow® 5 mL Luer-Slip Loss of Resistance Syringe Preox LOR Syringe BD Eclipse Hypodermic Needle Arrow MAC(TM) Two-Lumen Central Venous Access Kit 2-Lumen Central Venous Access (MAC)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device