FDA Registration Active 🇺🇸 United States

Arrow International, LLC (subsidiary of Teleflex Incorporated)

Reg #: 3015859709 · FEI: 3015859709 · Expires 2026
Products
49
Proprietary Names
336
Establishment Types
1
Classifications
49

Registration Details

Registration Name
Arrow International, LLC (subsidiary of Teleflex Incorporated)
Registration Number
3015859709
FEI Number
3015859709
Status
Active
Expiry Year
2026
Initial Importer
No
Address
35 Innovation Way
City
Wyomissing
State
PA
ZIP
19610
Country
US

Regulatory Submissions

510(k) Number
K071538

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

Products

Device Name Product Code
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Catheter, Percutaneous DQY
Catheter, Ultrasound, Intravascular OBJ
Needle, Hypodermic, Single Lumen FMI
Midline Catheter PND
Anesthesia Conduction Kit CAZ
Catheter, Conduction, Anesthetic BSO
Catheter, Hemodialysis, Implanted MSD
Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
Wire, Guide, Catheter DQX
Drape, Surgical, Antimicrobial KKX
Gown, Surgical FYA
System, Balloon, Intra-Aortic And Control DSP
Introducer, Catheter DYB
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Multi-Lumen Hemodialysis Catheterization Kit PPO
Orthosis, Lumbo-Sacral IPY
Set, Administration, Intravascular FPA
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Catheter Introducer Kit OFC
Catheter And Tip, Suction JOL
Catheter Guide Wire Kit OFB
Kit, Surgical Instrument, Disposable KDD
Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. DOY
Stylet, Catheter DRB
Kit, Repair, Catheter, Hemodialysis NFK
Catheter, Irrigation GBX
Syringe, Piston FMF
Device, Intravascular Catheter Securement KMK
Epidural Anesthesia Kit OGE
Accessories, Catheter KGZ
Prosthesis, Elbow, Constrained, Cemented JDC
Catheter, Intravascular, Diagnostic DQO
Catheter, Hemodialysis, Non-Implanted MPB
Catheter, Flow Directed DYG
Peripheral Catheter Insertion Kit OWL
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
Staple, Removable (Skin) GDT
Needle, Aspiration And Injection, Disposable GAA
Scalpel, One-Piece GDX
Electrode, Needle GXZ
Electrode, Pacemaker, Temporary LDF
Catheter, Peritoneal GBW
Percutaneous Atrial Catheter Kit OFK
Cannula, Surgical, General & Plastic Surgery GEA
Chest Drainage Kit PAD
Suture, Nonabsorbable, Silk GAP
Catheter, Embolectomy DXE
Catheter, Hemodialysis, Triple Lumen, Non-Implanted NIE

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 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 VectorFlow Retrograde Replacement Hub Set AHDC AGB KIT 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 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 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 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 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 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 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 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 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 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 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® Continuous Epidural Needle 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 StimuCath (19 Ga) Brachial Plexus Catheter Arrow Single Shot or Continuous (Intermittent) Brachial Plexus Set INTRODUCER & INJECTION NEEDLES Vascular Positioning System¿ (VPS¿) Stylet Arrow MAC(TM) Two-Lumen Central Venous Access Kit 2-Lumen Central Venous Access (MAC) Pressure Injectable PICC PICC v2 Arrow PICC 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 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 FlexTip Plus Epidural Catheterization Kit FlexTip Plus Combined Spinal Epidural Catheterization Kit Balloon Wedge Pressure Catheter Arrow SharpsAwayII¿ Locking Disposal Cup SharpsAway Needle Disposal Cups Arrow® Temporary Pacing Catheters, Arrow® BiPolar Pacing Catheters Arrow® Wedge Pressure Catheter, EZ-MIO, EZ-IO DISTAL TIBIA Antecubital Central Venous Catheterization Kit with Heparin-Coated Catheter 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 Kit Arrowg+ard Blue Advance™ PICC with 80 cm Hydrophilic-Coated Nitinol Guidewire Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Mapping/Pacing Catheter EZ-IO Arrow Peritoneal Lavage Catheterization Kit ARROW PERITONEAL LAVAGE KIT Pneumothorax Set MANUAL PD-IO; POWERED PD-IO Raulerson Syringe Arrow Raulerson Syringe Arrow® 10 mL Luer-Slip Loss of Resistance Syringe Arrow® 5 mL Luer-Slip Loss of Resistance Syringe Preox LOR Syringe Percutaneous Sheath Introducers Arrow Catheter Clamp for 5, 6, 7 and 8 Fr. Catheters RA Catheter w/Integral Ndl Protect ARROW Radial Artery Catheterization Set with Integral Needle Protection POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO NaviCurve Stylet TipTracker Stylet VPS Rhythm DLX Device with TipTracker Technology Arrow VPS G4 Arrow Twin-Cath(R) 20/22 Multiple-Lumen Peripheral Catheter TwinCath Intravenous Catheters Transduction probe Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC) Arrow Non-Absorbable Silk Suture Silk Suture Catheter Clamp with Fastener CathGuard Pressure Injectable Peripherally Inserted Catheter Multi-Lumen CVC none Spring Wire Guide Walrus Multi-Lumen Intravenous Infu Walrus embolectomy catheter Embolectomy Catheter Celerity PICC Tip Confirmation System POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility