Data / Medical devices / United States / Arrow International, LLC (subsidiary of Teleflex, Incorporated)
Arrow International, LLC (subsidiary of Teleflex, Incorporated): FDA-registered device maker in Chelmsford, MA, United States, 25 510(k) clearances
Arrow International, LLC (subsidiary of Teleflex, Incorporated) is registered with the FDA (registration 3010532612) in Chelmsford, MA, United States. It lists 11 device types. The FDA files 25 510(k) clearances under its listings, the newest dated March 26, 2025. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010532612
- Address
- 16 Elizabeth Dr, Chelmsford, MA, United States, 01824
- Owner or operator
- Arrow International LLC (subsidiary of Teleflex Incorporated (2518433)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 16, 2001
- Registered through
- 2026
- Brand names listed
- 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 Range Intra-Aortic Balloon Pump, AC3 Series IABP, AGBA PICC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Catheterization Kit | OES | 2 | Manufacturer | accessdata.fda.gov |
| Cardiovascular Procedure Kit | OEZ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Flow Directed | DYG | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrode, Pacemaker, Temporary | LDF | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
| System, Balloon, Intra-Aortic And Control | DSP | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| March 26, 2025 | K250542 | AC3 Range Intra-Aortic Balloon Pump | DSP | Substantially Equivalent | Arrow International, LLC | accessdata.fda.gov |
| August 30, 2023 | K232343 | AC3 Series IABP | DSP | Substantially Equivalent | Arrow International, LLC | 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 |
| June 28, 2019 | K190101 | UltraFlex IAB | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| March 31, 2017 | K162820 | AC3 Series IABP System | DSP | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| April 6, 2006 | K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | DSP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 27, 2004 | K042126 | PICC | LJS | Unknown | 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 |
| March 2, 2001 | K010330 | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U | DSP | Substantially Equivalent | Arrow Intl., 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 |
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, 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 |
| 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 |
| 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 10, 2016 | 73266 | Class I | Terminated | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply t | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | accessdata.fda.gov |
| October 11, 2010 | 56965 | Not yet classified | Terminated | Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U | SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. | accessdata.fda.gov |
| February 2, 2009 | 51080 | Not yet classified | Terminated | 8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon infl | A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. | accessdata.fda.gov |
| November 4, 2003 | 27681 | Not yet classified | Terminated | Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06520) Product # AP-06520 kit contains 1 implantable titanium port, 2 attachable silicone rubb | The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Flow Directed
- All makers of System, Balloon, Intra-Aortic And Control
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Cardiovascular Procedure Kit
- All makers of Catheter, Intravascular, Diagnostic
Updated March 26, 2025. 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.