Data / Medical devices / Czechia / Arrow International CR, a.s.

Arrow International CR, a.s.: FDA-registered device maker in Hradec Kralove, Czechia, 47 510(k) clearances

Name: Arrow International CR, a.s. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Arrow International CR, a.s. is registered with the FDA (registration 1000563940) in Hradec Kralove, Czechia. It lists 23 device types. The FDA files 47 510(k) clearances under its listings, the newest dated August 21, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1000563940
Address: Prazska 209, Hradec Kralove, Czechia, 50004
Owner or operator: Arrow International LLC (subsidiary of Teleflex Incorporated (2518433)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: February 6, 1998
Registered through: 2026
Brand names listed: 14 Fr 2-L Hemodialysis Catheters, 2-Lumen Central Venous Access (MAC), AGB+ Multi-Lumen CVC Kit, AGB+ Quad Lumen CVC Kit, AGB+ Two-Lumen CVC Kit, ARROW Radial Artery Catheterization Set with Integral Needle Protection, ARROWg+ard 2-L Access (MAC), ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer	accessdata.fda.gov
Anesthesia Conduction Kit	CAZ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Contract manufacturer	accessdata.fda.gov
Catheter, Conduction, Anesthetic	BSO	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Catheter, Flow Directed	DYG	2	Manufacturer	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted	MPB	2	Manufacturer	accessdata.fda.gov
Catheter, Hemodialysis, Triple Lumen, Non-Implanted	NIE	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Subclavian	LFJ	2	Manufacturer	accessdata.fda.gov
Chest Drainage Kit	PAD	2	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Repackager or relabeler	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 21, 2019	K190026	Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)	BSP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
June 23, 2017	K171146	Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.	DQY	Substantially Equivalent	Arrow International, Inc. (Subsidiary of Telelflex Inc.)	accessdata.fda.gov
March 17, 2017	K162522	UltraCath Continuous Nerve block Catheter	BSO	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
June 21, 2016	K153652	ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set	CAZ	Substantially Equivalent	Teleflex, Inc.	accessdata.fda.gov
May 27, 2016	K161170	BD Eclipse Hypodermic Needle	FMI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 24, 2015	K143102	Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions	NIE	Unknown	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	accessdata.fda.gov
March 27, 2015	K140110	FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET	BSO	Substantially Equivalent	Teleflex, Inc.	accessdata.fda.gov
September 28, 2012	K121462	EZ-BLOCKER	CBI	Substantially Equivalent	Ez-Blocker B.V.	accessdata.fda.gov
August 28, 2012	K122027	ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER	CAZ	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
June 20, 2012	K121403	CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET	CAZ	Substantially Equivalent	Teleflex, Inc.	accessdata.fda.gov
May 16, 2012	K103658	FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER	CAZ	Substantially Equivalent	Teleflex, Inc.	accessdata.fda.gov
December 18, 2009	K093050	ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520	DQY	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
December 9, 2008	K082297	BUSSE SURGICAL DRAPE	KKX	Substantially Equivalent	Busse Hospital Disposables, Inc.	accessdata.fda.gov
August 30, 2007	K071538	ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER	FOZ	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
April 23, 2003	K030937	STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK	CAZ	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
February 11, 2003	K023419	TRILAMINATE DRAPES/TIBURON	KKX	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
October 18, 2002	K022895	ELCAM STOPCOCKS AND MANIFOLDS	FMG	Substantially Equivalent	Medical Device Consultants, Inc.	accessdata.fda.gov
June 19, 2002	K021567	STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000	CAZ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
May 2, 2002	K021120	RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP	DQY	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
October 31, 2001	K011761	MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT	DYB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
March 21, 2001	K002507	TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT	DYB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
September 14, 2000	K993933	14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO	MPB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
September 1, 2000	K002508	EQUIPMENT DRAPES	KKX	Substantially Equivalent	Allegiance Healthcare Corp.	accessdata.fda.gov
August 29, 2000	K001731	AVID-NIT LOSS OF RESISTANCE SYRINGE	FMF	Substantially Equivalent	Avid Medical, Inc.	accessdata.fda.gov
March 8, 2000	K993691	ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER	FOZ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
May 26, 1999	K991431	14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT	MPB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
May 18, 1999	K984022	PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT	MPB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
February 13, 1998	K970229	ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET	DYB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
October 17, 1997	K970864	ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS	FOZ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
August 21, 1997	K962577	ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER	FOZ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
November 30, 1994	K940079	ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903	DYB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
August 15, 1993	K924385	NEW HYDROPHILIC COATING FOR WIRE GUIDES	DQX	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
June 18, 1993	K925126	INTERLINK(TM) INJECTION SITE	FPA	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
February 27, 1992	K914531	STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES	DQX	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
July 24, 1990	K900263	ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER	FOZ	Unknown	Arrow Intl., Inc.	accessdata.fda.gov
January 3, 1990	K895417	ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT	LFJ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
December 27, 1989	K895516	CAVITY DRAINAGE CATHETERIZATION SET, CS-01600	GBX	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
March 14, 1989	K884552	CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER	CAZ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
August 25, 1986	K862056	[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP	DQY	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
December 3, 1985	K854137	ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC	DQY	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
January 30, 1984	K833918	INFUSION PORT BALLOON THERMODILUTION	DYG	Substantially Equivalent	Critikon Company, LLC	accessdata.fda.gov
January 22, 1982	K820009	ARROW JUGULAR PUNCTURE KIT 16 GA.	DQY	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
March 27, 1981	K810675	ARROW RADIAL ARTERY CATHETERIZATION SET	DQX	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
October 23, 1980	K802367	ARROW CATHETER CLAMP	KGZ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
September 16, 1980	K801912	ARROW POSITIVE PLACEMENT CON/EPIDURAL AN	CAZ	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
April 21, 1978	K780532	PERCUTANEOUS SHEATH INTRODUCER KIT	DYB	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
June 14, 1977	K770977	CARDIOVASCULAR SPRING GUIDES	DQX	Substantially Equivalent	Lake Region Mfg., Inc.	accessdata.fda.gov

Compare with other makers

Updated August 21, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.