# Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

- Location (FDA's records): Reading, PA
- FDA decisions: 17 (2012–2022): 17 510(k) clearances
- Names in FDA's records: Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (8); Arrow International (Subsidiary of Teleflex Inc.) (6); Arrow International, Inc. (Subsidiary of Teleflex (2); Arrow International, LLC Subsidiary of Teleflex Incorporated (1)
- Product codes: LJS (8), PND (2), FOZ (2), NIE (1), OBJ (1), DYB (1), FMI (1), DQX (1)
- 510(k) review time since 2016: median 71 days, against 128 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 28 (9 its own); citations of its devices by later devices: 17 (9 its own)
- Recalls linked to its devices: 46 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vasonova, Inc.: 4 (https://510kreport.com/company/vasonova)
- Arrow Intl., Inc.: 4 (https://510kreport.com/company/arrow-intl)
- Arrow International, Inc.: 3 (https://510kreport.com/company/arrow-international)
- Arrow Internation, Inc. (Subsidiary of Teleflex Inc.): 2 (https://510kreport.com/company/arrow-internation-subsidiary-of-teleflex)
- Arrow International, Inc (Subsidiary of Teleflex I: 1 (https://510kreport.com/company/arrow-international-subsidiary-of-teleflex-i)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Medical Components, Inc.: 1 (https://510kreport.com/company/medical-components)
- Xentek Medical, Inc.: 1 (https://510kreport.com/company/xentek-medical)

## Firms that cite its devices most
- Arrow International, LLC (A subsidiary of Teleflex, Inc.): 3 (https://510kreport.com/company/arrow-international-a-subsidiary-of-teleflex)
- Arrow International, Inc (Subsidiary of Teleflex I: 2 (https://510kreport.com/company/arrow-international-subsidiary-of-teleflex-i)
- Actuated Medical, Inc.: 1 (https://510kreport.com/company/actuated-medical)
- Arrow International, Inc.: 1 (https://510kreport.com/company/arrow-international)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)

## Its most-cited devices
- K112896: Arrw Evolution (2012), cited by 4
- K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet (2013), cited by 2
- K163513: Arrow Endurance Extended Dwell Peripheral Catheter System (2017), cited by 2
- K123759: CG+ Arrow Picc Powered by Arrow VPS Stylet (2013), cited by 2
- K180395: EZ-IO Intraosseous Vascular Access System (2018), cited by 2
- K121501: Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) (2012), cited by 1

## Recent decisions
- K213855: Arrow Pressure Injectable Midline Catheter (Sep 2, 2022)
- K180395: EZ-IO Intraosseous Vascular Access System (Nov 9, 2018)
- K163513: Arrow Endurance Extended Dwell Peripheral Catheter System (Feb 24, 2017)
- K161765: CG+ Arrow JACC (Sep 6, 2016)
- K161313: ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (Aug 24, 2016)
- K160018: Arrow Quickflash Arterial Catheterization Device (Jun 13, 2016)
- K153487: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS (Feb 4, 2016)
- K153423: CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC (Jan 28, 2016)

Source page: https://510kreport.com/company/arrow-international-subsidiary-of-teleflex