# Arrow International, Inc.

- Location (FDA's records): Reading, PA
- FDA decisions: 22 (2003–2025): 22 510(k) clearances
- Names in FDA's records: Arrow International, Inc. (19); Arrow International, LLC (3)
- Product codes: DSP (7), LJS (5), MSD (4), CAZ (4), FOZ (1), DQX (1)
- 510(k) review time since 2016: median 157 days, against 140 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 37 (10 its own); citations of its devices by later devices: 30 (10 its own)
- Recalls linked to its devices: 114 (23 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arrow Intl., Inc.: 11 (https://510kreport.com/company/arrow-intl)
- Teleflexmedical, Inc.: 3 (https://510kreport.com/company/teleflexmedical)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Diatek, Inc.: 2 (https://510kreport.com/company/diatek)
- Teleflex, Inc.: 2 (https://510kreport.com/company/teleflex)
- Arrow International, Teleflex: 1 (https://510kreport.com/company/arrow-international-teleflex)
- Bard Access Systems, Inc.: 1 (https://510kreport.com/company/bard-access-systems)
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)

## Firms that cite its devices most
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.): 3 (https://510kreport.com/company/arrow-international-subsidiary-of-teleflex)
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)
- Teleflex, Inc.: 2 (https://510kreport.com/company/teleflex)
- Arrow Intl., Inc.: 2 (https://510kreport.com/company/arrow-intl)
- Arrow International, LLC (A subsidiary of Teleflex, Inc.): 2 (https://510kreport.com/company/arrow-international-a-subsidiary-of-teleflex)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Epimed International, Inc.: 1 (https://510kreport.com/company/epimed-international)

## Its most-cited devices
- K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter (2007), cited by 5
- K080604: Pressure Injfectable Picc (2008), cited by 4
- K030937: Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK (2003), cited by 4
- K061289: Arrow Pressure Injectable Picc (2006), cited by 3
- K040078: Cannon II Plus (2004), cited by 2
- K073451: Pressure Injectable Picc (2008), cited by 2

## Recent decisions
- K250542: AC3™ Range™ Intra-Aortic Balloon Pump (Mar 26, 2025)
- K232343: AC3™ Series IABP (Aug 30, 2023)
- K222341: Arrow 0.2 Micron Flat Filter, GVS (Feb 13, 2023)
- K201112: AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (May 27, 2020)
- K200634: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (Apr 9, 2020)
- K190101: UltraFlex IAB (Jun 28, 2019)
- K190117: Fiberoptix IAB (Jun 13, 2019)
- K162820: AC3 Series IABP System (Mar 31, 2017)

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