# Arrow International, LLC (A subsidiary of Teleflex, Inc.)

- Location (FDA's records): Morrisville, NC
- FDA decisions: 6 (2015–2025): 6 510(k) clearances
- Names in FDA's records: Arrow International, LLC (A subsidiary of Teleflex, Inc.) (4); Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) (1); Arrow International (A Subsidiary of Teleflex, Inc.) (1)
- Product codes: FOZ (3), LJS (2), DRB (1)
- 510(k) review time since 2016: median 168 days, against 153 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.): 3 (https://510kreport.com/company/arrow-international-subsidiary-of-teleflex)
- Arrow International, Inc.: 2 (https://510kreport.com/company/arrow-international)
- Nostix, LLC: 1 (https://510kreport.com/company/nostix)
- Galt Medical Corp.: 1 (https://510kreport.com/company/galt-medical)
- Navilyst Medical, Inc.: 1 (https://510kreport.com/company/navilyst-medical)

## Firms that cite its devices most
- Piccolo Medical, Inc.: 1 (https://510kreport.com/company/piccolo-medical)

## Its most-cited devices
- K160925: VPS Rhythm Device with TipTracker Technology (2016), cited by 2

## Recent decisions
- K243599: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (Mar 14, 2025)
- K242281: Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) (Dec 20, 2024)
- K220280: Arrow Stiffening Stylet (Aug 30, 2022)
- K220363: VPS Rhythm DLX Device with TipTracker Technology (Aug 22, 2022)
- K160925: VPS Rhythm Device with TipTracker Technology (Dec 22, 2016)
- K150109: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology (Jun 5, 2015)

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