Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015859709

FEI Number

3015859709

Entity Name

Arrow International, LLC (subsidiary of Teleflex Incorporated)

City/State/Country

Wyomissing, PA, US

Establishment Address

35 Innovation Way, Wyomissing, PA 19610, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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 Pressure Injectable Central Venous Catheterization Kit Ag+ & Ag+BP Pressure Injectable CVC Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography Arrow-Johans ECG Adapter Arrow(TM) Endurance(TM) Extended Dwell Peripheral Catheter System Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS EZ-MIO STERNAL Arrow Pressure Injectable Midline UltraCath Continuous Nerve Block Kit UltraCath Continuous Nerve Block Catheter NextStep Retrograde Edge Cannon II Plus Arrow® QuadPolar Electrode Catheter Arrow® QuadPolar Mapping/Pacing Catheter NEW HYDROPHILIC COATING FOR WIRE GUIDES Arrow Echogenic Introducer Needle Echogenic Introducer Needle Catheter Hemodialysis Arrow Jugular Puncture Kit Single Lumen CVCs Drape surgical Continuous Epidural Anesthesia Kits EZ-IO INTRAOSSEOUS INFUSION SYSTEM Cannon Hemodialysis Catheter Arrow Echogenic Introducer Needle Echogenic Introducer needle AC3 Series IABP System AC3 AC3 Optimus Transseptal Super ArrowFlex PSI Arrow® Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set Ag+ Super ArrowFlex PSIs Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath NextStep Antegrade 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 ORTHOSIS, LUMBO-SACRAL Extension Tubing High Flow Fluid Administration Set Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle Arrow StimuQuik Insulated Peripheral Nerve Block Needle Arrow® Sheath Adapter with Cath-Gard® Catheter Contamination Shield Sheath Adapter Multiple Arrowg+ard Blue Advance PICC pre-loaded with ARROW® VPS® Stylet Arrowg+ard Blue Advance PICC EZ-MIO MANUAL DRIVER Arrowg+ard Blue Advance PICC pre-loaded with ARROW® VPS® Stylet FAST Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device PSI KIT 2 LUMEN/PSI KIT GLIDETHRU MAC SET AM PICC PSI KIT/AGB CVC KIT AGB MAC KIT MULTILUMEN/MAC KIT EMERGENCY INFUSION DEVICE MAC KIT ACCESSORY KIT MULTI-LUMEN/PSI KIT PSI ACCESS TRAY PSI SET PSI/CVC KIT 2-L MAC KIT MAC SEMI KIT PSI SEMI KIT TRAUMA SET Arrow UserGard(R) Needle-Free Injection Hub USER-GARD NEEDLESS INJECTION HUB Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter M-L CVC w/BlueFlex Tip EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SWG Arrow-Clarke Pleura-Seal® Thoracentesis Set ARROW THORACENTESIS KIT Arrow-Clarke Pleura-Seal Thoracentesis Kit Arrow Endurance Extended Dwell Peripheral Catheter System 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 ARROW® FlexBlock Continuous Peripheral Nerve Block Sets ARROW® FlexBlock Continuous Peripheral Nerve Block Kits ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter Edge Radial Artery Catheter Arterial Access Tray Art./Venous Cath Set Arterial Catheter Kit RA Cath Kit Arterial Cath Kit Arterial Catheterization Kit Arterial Line Kit CVC Kit Spring Wire Guide Component Micro Introducer Set Abdominal Paracentesis Kit Walrus Percutaneous Introducer Set Anesthesia Conduct Kit Single Shot Epidural Arrow Single Shot Epidural Anesthesia Kit Arrow Stiffening Stylet Arrow Peripherally Inserted Central Catheter PICC Peripherally Inserted Central Catheter Cannon II Plus Replacement Hub Set NextStep Retrograde Replacement Hub Set Arrow Seldinger Arterial Catheterization Device Percutaneous Cavity Drainage Catheterization Set/Kit PERCUTANEOUS CAVITY DRAI Arrowg+ard Blue Advance Midline Arrow Continuous Nerve Block Needle Arrow Stimulator Adapter Cable Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile) Arrow StimuCath® Continuous Nerve Block Set Arrow FlexBlock Continous Peripheral Nerve Block Kits Super Arrow-Flex® Percutaneous Sheath Introducer Set Super ArrowFlex PSIs Vessel catheterization Kit/Set Arrow Select Kits VIDAPORT INTRAOSSEOUS INFUSION SYSTEM - Arrow PICC Powered by Arrow VPS Stylet Arrow Central Venous Catheterization Kit Puncture Kit, Disposable Vein CELERITY SYSYEM Arrow Radial Artery Arterial Catheter Intravascular catheter securement Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter Arrow® Access Tray Arrow Epidural Catheterization Set with FlexTip Plus® Closed Tip Multi-Port Catheter Arrow Epidural Catheterization Kit with TheraCath® Arrow Epidural Anesthesia Kit Arrow Epidural Catheterization Kit with TheraCath® Catheter Epidural Catheterization Kit Arrow Access Tray Arrow Single Shot Epidural Anesthesia Kit Arrow Epidural Catheterization Kit Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter Arrow Epidural Needle Arrow Epidural Needle Kit Percutaneous TPN Kit Arrow "No Leak" Sheath Adapter with Side Port Catheter Hemodialysis Arrowg+ard Blue Advance JACC Arrow® MultiPolar Mapping/Pacing Catheter Arrow® MultiPolar Electrode Catheter Pneumothorax Kit Pneumothorax kit w/Sutures Internal Jugular Kit Arrow® Arterial Catheterization Set Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter Pediatric 2-L Hemodialysis Catheter EZ-IO Intraosseous Vascular Access System Heparin Coated Thermodilution Ballo Arrow® Thermodilution Catheters EZ-IO INTRAOSSEOUS INFUSION SYSTEM Arrow(TM) Endurance(TM) Extended Dwell Peripheral Catheter System Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter Ag+ Quad Lumen CVCs 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 Large Bore Multi-Lumen CVCs Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter 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 Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter ARROWg+ard CVCs NextStep Retrograde (femoral lengths) 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 Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device ARROWg+ard 2-L Access (MAC) HUMERAL HEAD, MANUAL DRIVER Arrow PSI PERCUTANEOUS SHEATH INTRODUCER Staple Anchoring Device 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 Arrowg+ard Blue Advance PICC pre-loaded with Arrow® TipTracker Stylet VectorFlow Retrograde Replacement Hub Set VectorFlow Retrograde Chronic Hemodialysis Catheter VectorFlow Antegrade Chronic Hemodialysis Catheter Arrow-Clark VectorFlow Retrograde Hemodialysis Catheterization Set Arrow-Clark VectorFlow Retrograde Replacement Hub Set Arrow-Clark VectorFlow Antegrade Hemodialysis Catheterization Set 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 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 Emergency Infusion Device Trauma Kit Arrow® Emergency Infusion Device - EID¿ Drape, surgical Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature Arrow TheraCath® Epidural Catheter Arrow Epidural Catheterization Kit with TheraCath® Catheter StimuCath (19 Ga) Brachial Plexus Catheter Arrow Single Shot or Continuous (Intermittent) Brachial Plexus Set INTRODUCER & INJECTION NEEDLES Vascular Positioning System¿ (VPS¿) Stylet Cannon II Plus Arrow MAC(TM) Two-Lumen Central Venous Access Kit 2-Lumen Central Venous Access (MAC) Pressure Injectable PICC Multiple PICC v2 Arrow PICC 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 Hands-off Thermodilution Catheters 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 VPS Vascular Positioning System Arrow StimuQuik® Echo Insulated Peripheral Nerve Block Needle Arrow StimuQuik® Insulated Peripheral Nerve Block Needle TFX MEDICAL INTRODUCER ASSEMBLY Radiopaque polyurethane multi-lumen indwelling catheter with heparing coating MIDLINE CATHETERS PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE AM/AT PICC PICC with Chlorag+ard Technology ARROWg+ard Evolution Antimicrobial Pressure Injectable PICC CG+ PICC Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus Epidural Catheterization Kit FlexTip Plus Combined Spinal Epidural Catheterization Kit Balloon Wedge Pressure Catheter

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	2008-02-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-03-31
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2015-11-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
PND	Midline Catheter	General Hospital	Class 2	880.5200	2022-09-12
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-03-20
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2017-03-20
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2013-01-17
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2012-04-18
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-06-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-14
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
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
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-02-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-02-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-02-15
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2017-04-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-02-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2015-12-10
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2012-04-18
PPO	Multi-Lumen Hemodialysis Catheterization Kit	Gastroenterology, Urology	Class 2	876.5540	2025-12-18
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2020-10-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-08-29
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2018-08-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-02-24
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-10-14
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2026-01-15
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	1998-03-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	1998-02-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-11-17
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2006-06-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-03-31
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-05-19
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-12
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
OFB	Catheter Guide Wire Kit	Cardiovascular	Class 2	870.1330	2026-01-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-12-13
DOY	Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.	Clinical Toxicology	Class 2	862.3320	2009-12-17
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2022-09-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2008-02-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-07-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2006-06-19
PND	Midline Catheter	General Hospital	Class 2	880.5200	2016-10-21
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2018-03-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-02-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-02-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-12-16
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-08-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-13
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-01-22
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2010-11-19
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-15
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2008-02-15
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2011-04-28
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-02-24
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2014-02-24
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-13
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2010-02-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2015-11-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-01-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-01-15
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	2020-10-14
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-01-28
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	2012-05-31
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-12-13
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2026-01-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-12-13
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-01-23
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-02-15
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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-02-06
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2008-06-03
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	2017-01-03
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2014-07-16
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-07-16
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-03-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-02-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1995-02-02
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2012-10-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-12-14
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
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2009-08-04
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-04
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2014-02-19
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2008-07-23
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-02-05
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2015-04-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-02-15
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2008-02-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-03-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2007-02-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-06-03
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2010-11-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2016-03-22
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2016-03-22
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2008-02-15

Official Correspondent

Divya Raman

US Agent Details

No US Agent registered (Local establishment).

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
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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2007	Arrow International Inc	2	Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
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

Similar Registrations

Registration Number	Establishment Name	Location
2245270	VYGON USA	Lansdale, PA, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3012809732	SHIPSERVE NEW ZEALAND LIMITED	Ellerslie Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015859709. Last updated year: 2026. Please use registration number 3015859709 when referencing this establishment in official correspondence.