Arrow International, LLC (subsidiary of Teleflex, Incorporated)

FDA Device Registration & Listing · Chelmsford, MA, US · Registration 3010532612

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010532612
FEI Number
3010532612
Entity Name
Arrow International, LLC (subsidiary of Teleflex, Incorporated)
City/State/Country
Chelmsford, MA, US
Establishment Address
16 Elizabeth Dr, Chelmsford, MA 01824, 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
N
Expiration Date (Year)
2026
510(k) Number
K945229
PMA Number
N/A

All Registered Proprietary Names

Balloon Catheter RediGuard IABs ARROW INTRA-AORTIC BALL UltraFlex™ IAB RediGuard® Intra-Aortic Balloon System RediGuard® Intra-Aortic Balloon Catheter Arrow® QuadPolar Electrode Catheter Arrow® QuadPolar Mapping/Pacing Catheter AC3 Series Intra-Aortic Balloon Pump (IABP) AutoCAT®2 Intra-Aortic Balloon Pump, AutoCAT2WAVE® Intra-Aortic Balloon System AUTOPILOT® AutoCAT2WAVE® Intra-Aortic Balloon Pump, AutoCAT®2 Intra-Aortic Balloon System NarrowFlex® Intra-Aortic Balloon (IAB) System NarrowFlex® Intra-Aortic Balloon (IAB) Catheter 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 AC3™ Range™ Intra-Aortic Balloon Pump PICC Balloon Thermodilution Catheter Arrow® Thermodilution Catheters Arrow® Thermodilution Catheters Infusion Port Thermodilution FiberOptix® Intra-Aortic Balloon Catheter Kit AC3™ Series IABP Arrow Berman Catheter, Arrow Berman Angiographic Catheter, Wedge Pressure Catheters and Reverse Berman Catheters Balloon Wedge Pressure Catheter LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Mapping/Pacing Catheter Arrow® MultiPolar Mapping/Pacing Catheter Arrow® MultiPolar Electrode 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 2015-11-04
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2014-12-10
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2007-02-05
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2020-10-06
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2007-02-05
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-12-13
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2024-10-03
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2007-12-14
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2007-12-14
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2007-02-05
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2025-03-27
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2007-02-06
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2007-12-13
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2007-12-13
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2020-10-06
DSP System, Balloon, Intra-Aortic And Control Cardiovascular Class 2 870.3535 2024-10-03
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2007-12-13
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2008-02-15
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2006-06-19
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2022-06-10
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-12-13

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
3006425876 Arrow International C.R. a.s. ZDAR NAD SAZAVOU Vysocina, CZ
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
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23

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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010532612. Last updated year: 2026. Please use registration number 3010532612 when referencing this establishment in official correspondence.
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