Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006425876

FEI Number

3006425876

Entity Name

Arrow International C.R. a.s.

City/State/Country

ZDAR NAD SAZAVOU Vysocina, CZ

Establishment Address

JAMSKA 2359/47, ZDAR NAD SAZAVOU Vysocina 591 01, CZ

Establishment Type(s)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

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 none Vessel catheterization Kit/Set Arrow Select Kits Arrow FlexBlock Continous Peripheral Nerve Block Kits Hemodialysis (Acute) Products Marked Spring-Wire Guide with Arrow Advancer Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter WECK Suture, non absorbable-silk Intravascular catheter securement Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter M-L CVC w/BlueFlex Tip Drape, Surgical Catheter Hemodialysis Cannon Hemodialysis Catheter VectorFlow Retrograde Replacement Hub Set AHDC AGB KIT NextStep Antegrade Arrow-Clark VectorFlow Antegrade Hemodialysis Catheterization Set VectorFlow Retrograde Chronic Hemodialysis Catheter HEMODIALYSIS KIT AHDC AGB U-BEND KIT HEMODIALYSIS SET AHDC AGB CURVED KIT Cannon II Plus; Edge Cannon II Plus Replacement Hub Set NextStep Retrograde Replacement Hub Set NextStep Retrograde Arrow-Clark VectorFlow Retrograde Hemodialysis Catheterization Set Arrow-Clark VectorFlow Retrograde Replacement Hub Set NextStep Retrograde (femoral lengths) VectorFlow Antegrade Chronic Hemodialysis Catheter AHDC KIT LBCVC AGB KIT Gertie Marx ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS Arrow PSI PERCUTANEOUS SHEATH INTRODUCER Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus Epidural Catheterization Kit FlexTip Plus Combined Spinal Epidural Catheterization Kit Arrow Radial Artery Arterial Catheter EZ-BLOCKER ARROW® FlexBlock Continuous Peripheral Nerve Block Sets ARROW® FlexBlock Continuous Peripheral Nerve Block Kits ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter Hypodermic single lumen needle Arrow Peripherally Inserted Central Catheter PICC Peripherally Inserted Central Catheter Arrow® Arterial Catheterization Set Pressure Injectable Peripherally Inserted Catheter Raulerson Syringe Arrow Raulerson Syringe wrap, sterilzation Arrow Continuous Nerve Block Needle Arrow Stimulator Adapter Cable Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile) Arrow StimuCath® Continuous Nerve Block Set Arrow Pressure Injectable Central Venous Catheterization Kit Ag+ & Ag+BP Pressure Injectable CVC Sprotte NEW HYDROPHILIC COATING FOR WIRE GUIDES Arrow Non-Absorbable Silk Suture Silk Suture LBCVC KIT MULTILUMEN PI CVC KIT PI CG+ PICC SET MULTI LUMEN CVC KIT CVC KIT AM/AT PI MIDLINE PI CVC SET PI AGBA PICC KIT ACCESS KIT ARROW(R) VPS(R) ACCESS KIT PICC KIT AGBA PI MIDLINE PREP TRAY AGBA PICC CVC SET PI PICC QUAD LUMEN PI CVC KIT PICC SET PI MIDLINE PI CVC KIT CG+ PICC SET VESSEL CATH KIT INTRAVENOUS SET PREP KIT AM PICC SET PI CATHETER ACCESS TRAY PI MULTI LUMEN CVC AGBA PI PICC KIT PI JACC KIT MIDLINE CATHETER KIT Forceps Foosin Silk Suture Elcam Stopcock Suture, Nonabsorbable, Synthetic, Polyamide Arrow® 10 mL Luer-Slip Loss of Resistance Syringe Arrow® 5 mL Luer-Slip Loss of Resistance Syringe Preox LOR Syringe 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 ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC) Oxygenator, Cardiopulmonary Bypass INTRODUCER & INJECTION NEEDLES Arrow Central Venous Catheterization Kit Multi-Lumen CVC Drape, surgical Hands-off Thermodilution Catheters Arrow® Thermodilution Catheters Infusion Port Thermodilution S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS EF-05510N: FILTER COMPONENT NRFit GVS INSYTE INTRODUCER CATHETER Stopcock i.v. set StimuCath (19 Ga) GAUZE PADS Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter ARROWg+ard CVCs Heparin Coated Thermodilution Ballo Arrow® Thermodilution Catheters MIDLINE CATHETERS 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 Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter Pediatric 2-L Hemodialysis Catheter BD ECLIPSE HYPODERMIC NEEDLE Syringe SUR Betha Sheet Holder Multiple General Use Arrow Central Venous Catheterization Kit Puncture Kit, Disposable Vein BD Eclipse Hypodermic Needle Drape surgical Filter Needle Sponge Arrowg+ard Blue Advance PICC pre-loaded with Arrow® TipTracker Stylet Arrowg+ard Blue Advance PICC with 130 cm Hydrophilic-Coated Nitinol Guidewire Arrowg+ard Blue Advance PICC pre-loaded with Arrow® VPS Precision Stylet Arrowg+ard Blue Advance PICC Arrowg+ard Blue Advance PICC Kit Arrowg+ard Blue Advance PICC with 80 cm Hydrophilic-Coated Nitinol Guidewire 3-WAY STOPCOCK BD Piston Syringes Surgical Gown SMS with PE Layer PICC Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter Ag+ Quad Lumen CVCs Ag+ Super ArrowFlex PSIs Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath VASCUPUNCTURE PICC GUIDEWIRE Arrow Jugular Puncture Kit Single Lumen CVCs instrument forceps MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD Pressure Injectable PICC Multiple Arrow PICC Arrow MAC(TM) Two-Lumen Central Venous Access Kit 2-Lumen Central Venous Access (MAC) 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 Catheter Dilator Introducer Dilator Tissue Dilator Drape, Surgical Arrowg+ard Blue Advance PICC pre-loaded with ARROW® VPS® Stylet Arrowg+ard Blue Advance PICC 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 Drape, Surgical 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 Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature Arrow TheraCath® Epidural Catheter Arrow Epidural Catheterization Kit with TheraCath® Catheter Arrow "No Leak" Sheath Adapter with Side Port Super Arrow-Flex® Percutaneous Sheath Introducer Set Super ArrowFlex PSIs STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK UltraCath Continuous Nerve Block Kit UltraCath Continuous Nerve Block Catheter 2- Lumen PICC Products w/ Blue Flex Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and integral needle protection Peripherally Inserted central catheter (PICC) with Blue Syringe SWG Dressing commercial

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-02-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-03-01
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2007-12-13
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2015-11-06
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-01-12
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-01-22
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-02-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	1998-02-06
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
PPO	Multi-Lumen Hemodialysis Catheterization Kit	Gastroenterology, Urology	Class 2	876.5540	2025-12-18
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2009-07-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-03-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
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	2007-12-13
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2012-10-31
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-08
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-09-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-01-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-01-15
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2016-04-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-15
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2009-07-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-06-04
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-02-15
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2008-07-23
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2026-01-15
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-09-22
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-12-22
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2008-12-22
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2008-12-22
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-12-22
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2011-03-11
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-01-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-10-15
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2012-08-28
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-12-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-04-04
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1995-02-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-02-15
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2014-02-19
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-05-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2016-03-03
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2015-10-19
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-09-17
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
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-02-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-02-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-12-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-12-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-02-06
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2010-02-09
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2010-02-09
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2016-01-21
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2016-06-30
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2012-06-07
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2016-03-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-11-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-11-19
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2010-11-19
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-09-16
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-06-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2015-06-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2016-04-25
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2009-08-04
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
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2010-02-08
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-05-31
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-04-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2016-01-21
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2008-02-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-02-29
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-02-29
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-02-29
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-02-29
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2016-02-29
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-02-29
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-02-29
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-03-20
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2017-03-20
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-11-17
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-02-05

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
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
1000563940	Arrow International CR, a.s.	Hradec Kralove, CZ

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04

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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3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006425876. Last updated year: 2026. Please use registration number 3006425876 when referencing this establishment in official correspondence.