# LivaNova USA, Inc.

- Location (FDA's records): Arvada, CO
- FDA decisions: 5 (1997–2026): 3 510(k) clearances and 2 original PMA approvals
- Product codes: DWF (2), MNQ (1), DWE (1), LYJ (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 30 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cobe Cardiovascular, Inc.: 2 (https://510kreport.com/company/cobe-cardiovascular)
- Shiley, Inc.: 2 (https://510kreport.com/company/shiley)
- Sorin Group Italia S.R.L.: 1 (https://510kreport.com/company/sorin-group-italia)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Estech, Inc.: 1 (https://510kreport.com/company/estech)

## Recent decisions
- P250013: aura6000™ system (Mar 18, 2026)
- K250937: Venous Return Cannulae (Mar 11, 2026)
- K250283: RAP Femoral Venous Cannulae (Jul 10, 2025)
- K233702: SMARxT Tubing and Connectors (Aug 8, 2024)
- P970003: VNS Therapy System (Jul 16, 1997)

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