# Vygon USA

- Location (FDA's records): Lansdale Montgomery, PA
- FDA decisions: 4 (2018–2024): 4 510(k) clearances
- Product codes: FOZ (1), FPD (1), LJS (1), PND (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vygon Corp.: 2 (https://510kreport.com/company/vygon)
- Bard Access Systems, Inc.: 1 (https://510kreport.com/company/bard-access-systems)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Piccguard, LLC: 1 (https://510kreport.com/company/piccguard)

## Its most-cited devices
- K172899: Vygon PICCs (2018), cited by 1

## Recent decisions
- K243361: Nutrifit (Dec 19, 2024)
- K212370: Leaderflex Mini and Leaderflex Nano (Aug 29, 2022)
- K181208: Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter (Nov 2, 2018)
- K172899: Vygon PICCs (Feb 26, 2018)

Source page: https://510kreport.com/company/vygon-usa