# Vivasure Medical Limited

- Location (FDA's records): Galway, IE
- FDA decisions: 2 (2025–2026): 1 510(k) clearance and 1 original PMA approval
- Names in FDA's records: Vivasure Medical Limited (1); Vivasure Medical , Ltd. (1)
- Product codes: DYB (1), MGB (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)

## Recent decisions
- P250015: PerQseal® Elite Vascular Closure Device (Oct 16, 2026)
- K252309: PerQseal Introducers (Oct 23, 2025)

Source page: https://510kreport.com/company/vivasure-medical