Data / Medical devices / United States / Arrow International LLC (subsidiary of Teleflex Incorporated)
Arrow International LLC (subsidiary of Teleflex Incorporated): FDA-registered device maker in Morrisville, NC, United States, 59 510(k) clearances
Arrow International LLC (subsidiary of Teleflex Incorporated) is registered with the FDA (registration 3013162291) in Morrisville, NC, United States. It lists 27 device types. The FDA files 59 510(k) clearances under its listings, the newest dated September 18, 2024. 13 recall events name it as the recalling firm (8 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013162291
- Address
- 3015 Carrington Mill Blvd., Morrisville, NC, United States, 27560
- Owner or operator
- Arrow International LLC (subsidiary of Teleflex Incorporated (2518433)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 6, 1998
- Registered through
- 2026
- Brand names listed
- 0.2 Micron Filter, 0.2 Micron Flat Epidural Filter, AC3 Optimus, AC3 Series IABP System, AC3 Series IABP System, AutoCAT®2 Intra-Aortic Balloon Pump, AC3 Series Intra-Aortic Balloon Pump (IABP), AC3, AC3 Series IABP and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2024 | K241784 | Arrow® Nitinol Wire | DQX | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| August 30, 2023 | K232343 | AC3 Series IABP | DSP | Substantially Equivalent | Arrow International, LLC | accessdata.fda.gov |
| July 25, 2023 | K231924 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| February 13, 2023 | K222341 | Arrow 0.2 Micron Flat Filter, GVS | CAZ | Substantially Equivalent | Arrow International, LLC | accessdata.fda.gov |
| September 2, 2022 | K213855 | Arrow Pressure Injectable Midline Catheter | PND | Substantially Equivalent | Arrow International, LLC Subsidiary of Teleflex Incorporated | accessdata.fda.gov |
| August 30, 2022 | K220280 | Arrow Stiffening Stylet | DRB | Substantially Equivalent | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| March 22, 2021 | K202492 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| May 27, 2020 | K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| April 9, 2020 | K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| November 12, 2019 | K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | DSP | Substantially Equivalent | Arrow International, Teleflex | accessdata.fda.gov |
| August 21, 2019 | K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | BSP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| June 28, 2019 | K190101 | UltraFlex IAB | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| April 25, 2018 | K173321 | StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1) Peripheral Nerve Block Needle | BSP | Substantially Equivalent | Teleflex Medical | accessdata.fda.gov |
| March 31, 2017 | K162820 | AC3 Series IABP System | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| March 17, 2017 | K162522 | UltraCath Continuous Nerve block Catheter | BSO | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| December 22, 2016 | K160925 | VPS Rhythm Device with TipTracker Technology | LJS | Substantially Equivalent | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | accessdata.fda.gov |
| October 4, 2016 | K161075 | Arrow Epidural Catheter Kit | CAZ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| June 21, 2016 | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| June 26, 2015 | K143581 | Arrow Epidural Catheter Kit | CAZ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| March 27, 2015 | K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | BSO | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| January 18, 2013 | K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | OBJ | Substantially Equivalent | Vasonova, Inc. | accessdata.fda.gov |
| December 21, 2012 | K122690 | ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122027 | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 20, 2012 | K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| May 16, 2012 | K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| March 30, 2009 | K083784 | PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, | QEZ | Substantially Equivalent | Vascular Solutions, Inc. | accessdata.fda.gov |
| August 30, 2007 | K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| July 10, 2006 | K061771 | EZ-CONNECT | FPA | Substantially Equivalent | Vidacare Corporation | accessdata.fda.gov |
| April 6, 2006 | K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | DSP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| April 23, 2003 | K030937 | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| July 16, 2002 | K014246 | AVID-NIT NERVE STIMULATION NEEDLES | CAZ | Substantially Equivalent | Avid N.I.T., Inc. | accessdata.fda.gov |
| June 19, 2002 | K021567 | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| June 6, 2002 | K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 | DSP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 2, 2002 | K021283 | GUIDANT BALLOON CATHETER, SEVERAL MODELS | DQO | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 2, 2001 | K010330 | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U | DSP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 29, 2000 | K001731 | AVID-NIT LOSS OF RESISTANCE SYRINGE | FMF | Substantially Equivalent | Avid Medical, Inc. | accessdata.fda.gov |
| May 19, 2000 | K000729 | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL | DSP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 18, 2000 | K993966 | 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER | DSP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 16, 1998 | K981660 | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters | DSP | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 17, 1996 | K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER | LDF | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 8, 1995 | K945229 | ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS | DRF | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 15, 1993 | K924385 | NEW HYDROPHILIC COATING FOR WIRE GUIDES | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| June 18, 1992 | K911065 | ARROW QUADPOLAR MAPPING/PACING CATHETER | DRF | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 27, 1992 | K914531 | STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 18, 1991 | K905229 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS | FGE | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| November 6, 1989 | K895268 | ARROW HANDS-OFF THERMO-PACE | DQO | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| September 26, 1989 | K892530 | CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH | DYG | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 14, 1989 | K884552 | CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| November 24, 1987 | K874105 | BRACHIAL PLEXUS CATHETER - BP-01200 | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 20, 1987 | K873943 | CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 25, 1986 | K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 30, 1984 | K833918 | INFUSION PORT BALLOON THERMODILUTION | DYG | Substantially Equivalent | Critikon Company, LLC | accessdata.fda.gov |
| January 30, 1984 | K833572 | HEPARIN-COATED BALLOON THERMODILUT | DYG | Substantially Equivalent | Critikon Company, LLC | accessdata.fda.gov |
| November 30, 1982 | K823433 | BALLOON THERMODILUTION CATHETER #7164& | DYG | Substantially Equivalent | Critikon Company, LLC | accessdata.fda.gov |
| March 27, 1981 | K810675 | ARROW RADIAL ARTERY CATHETERIZATION SET | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| September 16, 1980 | K801912 | ARROW POSITIVE PLACEMENT CON/EPIDURAL AN | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| December 12, 1978 | K781978 | PUNCTURE KIT, DISPOSALBE VEIN | FMF | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| April 21, 1978 | K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 1, 1977 | K770356 | ANESTHESIA KIT, EPIDURAL, SINGLE SHOT | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 21, 2026 | 98793 | Class I | Ongoing | PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | accessdata.fda.gov |
| April 10, 2026 | 98745 | Class I | Ongoing | Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. | accessdata.fda.gov |
| March 11, 2026 | 98618 | Class II | Ongoing | Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the n | Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured | accessdata.fda.gov |
| July 26, 2024 | 95228 | Class II | Ongoing | Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter No | Reports have been received regarding open seals on the packaging. | accessdata.fda.gov |
| April 29, 2024 | 94526 | Class I | Ongoing | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or bloo | accessdata.fda.gov |
| February 12, 2024 | 94033 | Class I | Ongoing | ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF | Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from mul | accessdata.fda.gov |
| August 10, 2023 | 93014 | Class I | Ongoing | 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: Diagnos | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. | accessdata.fda.gov |
| August 10, 2023 | 92850 | Class II | Ongoing | Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. | accessdata.fda.gov |
| May 19, 2023 | 92377 | Class I | Ongoing | ARROW Endurance Extended Dwell Peripheral Catheter System | Potential for catheter separation or leakage | accessdata.fda.gov |
| October 27, 2022 | 91090 | Class I | Terminated | Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer | There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit. | accessdata.fda.gov |
| October 17, 2022 | 91021 | Class I | Ongoing | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | accessdata.fda.gov |
| September 14, 2022 | 90871 | Class II | Terminated | ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm,.018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, an | Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product | accessdata.fda.gov |
| May 5, 2022 | 90147 | Class II | Terminated | Arrow Three-Lumen CVC | Gravity flow rates on the affected product lidstock are incorrect. | accessdata.fda.gov |
Compare with other makers
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- All makers of System, Balloon, Intra-Aortic And Control
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Updated June 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.