Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000563940

FEI Number

1000563940

Entity Name

Arrow International CR, a.s.

City/State/Country

Hradec Kralove, CZ

Establishment Address

PRAZSKA 209, Hradec Kralove 50004, CZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Arrow International LLC (subsidiary of Teleflex Incorporated (Owner Number: 2518433)

Owner / Operator Contact Address

3015 Carrington Mill Blvd., Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K984022

PMA Number

N/A

All Registered 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 Arrow GPSCath Balloon Dilatation 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 Arrow GPSCath Balloon Dilatation Catheter 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 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 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 Nerve Block Needle Arrow Continuous Peripheral Nerve Block Kit Arrow Stimulator Adapter Cable Arrow Prep Tray Arrow Nerve Block Prep Tray Arrow StimuCath® Continuous Nerve Block Set Arrow Access Tray Arrow® Epidural Needle Arrow Epidural Anesthesia Kit Arrow Access Tray 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-10-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-12-04
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2007-12-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-10-14
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-05-31
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	1998-02-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-15
PAD	Chest Drainage Kit	General Hospital	Class 2	880.6740	2025-12-18
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-10-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-02-14
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-01-22
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-01-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-01-15
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2015-10-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-12-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-02-29
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2011-03-11
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2006-06-19
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-07-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-12-13
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-03-20
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2017-03-20
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2015-08-04
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-12
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2016-03-22
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2016-03-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2019-11-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-06-04
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-04
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-02-15

Official Correspondent

Divya Raman

US Agent Details

Divya Raman Business: Teleflex, Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

Arrow International LLC (subsidiary of Teleflex Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010532612	Arrow International, LLC (subsidiary of Teleflex, Incorporated)	Chelmsford, MA, US
3006425876	Arrow International C.R. a.s.	ZDAR NAD SAZAVOU Vysocina, CZ
3013162291	Arrow International LLC (subsidiary of Teleflex Incorporated)	Morrisville, NC, US
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
9680794	Arrow Internacional de Chihuahua S.A. de C.V.	CHIHUAHUA, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter	2026-02-13
K142654	Covidien, LLC	Fortrex 0.035 OTW PTA Balloon Catheter	2014-10-28
K202800	Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)	Pacific Plus PTA Catheter	2020-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000563940. Last updated year: 2026. Please use registration number 1000563940 when referencing this establishment in official correspondence.