Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013162291

FEI Number

3013162291

Entity Name

Arrow International LLC (subsidiary of Teleflex Incorporated)

City/State/Country

Morrisville, NC, US

Establishment Address

3015 Carrington Mill Blvd., Morrisville, NC 27560, US

Establishment Type(s)

Manufacture Medical 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

K160925

PMA Number

N/A

All Registered Proprietary Names

FiberOptix® Intra-Aortic Balloon Catheter Kit EZ-IO Single-Use Procedure Trays 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 Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Mapping/Pacing Catheter Arrow Radial Artery Arterial Catheter Arrow StimuQuik® Echo Insulated Peripheral Nerve Block Needle Arrow StimuQuik® Insulated Peripheral Nerve Block Needle Balloon Wedge Pressure Catheter AC3 Series Intra-Aortic Balloon Pump (IABP) Arrow® Nitinol Wire NEW HYDROPHILIC COATING FOR WIRE GUIDES Arrow® Thermodilution Catheters Infusion Port Thermodilution Intra-Aortic Balloon (IAB) Catheter AutoCAT®2 Intra-Aortic Balloon Pump (IABP) Fiber Optic System (FOS) FiberOptix® IAB Catheter, FIBEROPTIX® Intra-Aortic Balloon Catheter, Ultra 8® AutoCAT®2 Series RediGuard® Intra-Aortic Balloon Catheter AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP) AC3 Series IABP 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 0.2 Micron Filter 0.2 Micron Flat Epidural Filter 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 NarrowFlex® Intra-Aortic Balloon (IAB) System NarrowFlex® Intra-Aortic Balloon (IAB) Catheter Arrow Pressure Injectable Midline RediGuard IABs ARROW INTRA-AORTIC BALL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS Heparin Coated Thermodilution Ballo Arrow® Thermodilution Catheters Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature Arrow TheraCath® Epidural Catheter Arrow Epidural Catheterization Kit with TheraCath® Catheter Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle Arrow StimuQuik Insulated Peripheral Nerve Block Needle AC3 Series IABP System AC3 AC3 Optimus AutoCAT®2 Intra-Aortic Balloon Pump, AutoCAT2WAVE® Intra-Aortic Balloon System AUTOPILOT® AutoCAT2WAVE® Intra-Aortic Balloon Pump, AutoCAT®2 Intra-Aortic Balloon System Continuous Epidural Anesthesia Kits TROCAR Arrow® MultiPolar Mapping/Pacing Catheter Arrow® MultiPolar Electrode Catheter ARROW® FlexBlock Continuous Peripheral Nerve Block Sets ARROW® FlexBlock Continuous Peripheral Nerve Block Kits ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter RediGuard® Intra-Aortic Balloon System RediGuard® Intra-Aortic Balloon Catheter Arrow Central Venous Catheterization Kit Puncture Kit, Disposable Vein Arrow® 10 mL Luer-Slip Loss of Resistance Syringe Arrow® 5 mL Luer-Slip Loss of Resistance Syringe Preox LOR Syringe Rusch Silko Spray Arrow® Temporary Pacing Catheters, Arrow® BiPolar Pacing Catheters Arrow® Wedge Pressure Catheter, Anesthesia Conduct Kit Single Shot Epidural Arrow Single Shot Epidural Anesthesia Kit Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter FlexTip Plus Epidural Catheter FlexTip Plus Epidural Catheterization Kit FlexTip Plus Combined Spinal Epidural Catheterization Kit UltraFlex® Intra-Aortic Balloon (IAB) Catheter, UltraFlex® Intra-Aortic Balloon (IAB) System Ultra 8® Intra-Aortic Balloon (IAB) System Ultra 8® Intra-Aortic Balloon (IAB) Catheter Arrow Pressure Injectable Central Venous Catheterization Kit Ag+ & Ag+BP Pressure Injectable CVC Brachial Plexus Catheter Arrow Single Shot or Continuous (Intermittent) Brachial Plexus Set Pronto LP Extraction Catheter Hands-off Thermodilution Catheters Arrow Epidural Needle Arrow® QuadPolar Electrode Catheter Arrow® QuadPolar Mapping/Pacing Catheter 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 Arrow EZ-IO Intraosseous Vascular Access System EZ-CONNECT STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES 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 Arrow Stiffening Stylet Arrow Continuous Nerve Block Needle Arrow Stimulator Adapter Cable Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile) Arrow StimuCath® Continuous Nerve Block Set Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter M-L CVC w/BlueFlex Tip Arrowg+ard Blue Advance PICC pre-loaded with Arrow® TipTracker Stylet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2020-10-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-24
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-04
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-06-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-02-15
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2008-02-15
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2008-02-15
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2024-10-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-11-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-06-04
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2001-07-16
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2024-10-03
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-02-08
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2019-08-22
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-05-19
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-12-14
PND	Midline Catheter	General Hospital	Class 2	880.5200	2022-09-12
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-02-05
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2006-06-19
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
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
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2017-04-05
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-12-14
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2008-02-15
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2001-07-16
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-10-12
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-02-05
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2009-12-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-10-15
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2024-01-25
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2008-02-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2016-03-22
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2016-03-22
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2007-02-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2013-01-17
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2025-09-24
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2014-02-19
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2019-11-22
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-05-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-01-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-06-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-02-14
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2010-11-19
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2022-09-12
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-02-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	1998-02-06
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2017-01-03

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
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
K903893	Datascope Corp.	DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL	1990-10-19
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
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-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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3007965489	Datascope Corp	Wayne, NJ, US
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9680794	Arrow Internacional de Chihuahua S.A. de C.V.	CHIHUAHUA, MX
3010532612	Arrow International, LLC (subsidiary of Teleflex, Incorporated)	Chelmsford, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013162291. Last updated year: 2026. Please use registration number 3013162291 when referencing this establishment in official correspondence.