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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2008-02-15 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2007-12-13 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2015-11-04 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2015-06-03 |
| Midline Catheter | PND | Class 2 | General Hospital | No | 2022-09-12 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2017-03-20 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2017-03-20 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2012-04-18 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2007-12-13 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-06-04 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2010-02-09 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2010-02-09 |
| System, Balloon, Intra-Aortic And Control | DSP | Class 2 | Cardiovascular | No | 2017-04-05 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-02-06 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2015-12-10 |
| Multi-Lumen Hemodialysis Catheterization Kit | PPO | Class 2 | Gastroenterology, Urology | No | 2025-12-18 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2020-10-14 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2007-12-13 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2018-08-29 |
| Catheter Introducer Kit | OFC | Class 2 | Cardiovascular | No | 2026-01-15 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2006-06-19 |
| Catheter Guide Wire Kit | OFB | Class 2 | Cardiovascular | No | 2026-01-15 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2007-12-13 |
| Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | DOY | Class 2 | Clinical Toxicology | No | 2009-12-17 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2022-09-12 |
| Kit, Repair, Catheter, Hemodialysis | NFK | Class 2 | Gastroenterology, Urology | No | 2008-02-15 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2006-06-19 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2009-12-16 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2016-01-22 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2010-11-19 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2008-02-15 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2010-02-12 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2015-11-10 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2008-02-15 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2007-12-13 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2026-01-15 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2008-02-15 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2008-06-03 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 1995-02-02 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2008-07-23 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2008-02-15 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2008-02-15 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2006-06-23 |
| Percutaneous Atrial Catheter Kit | OFK | Class 2 | Cardiovascular | No | 2026-01-15 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2009-03-30 |
| Chest Drainage Kit | PAD | Class 2 | General Hospital | No | 2025-12-18 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2008-02-15 |
| Catheter, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2008-02-15 |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2015-08-04 |
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