# Sirtex Medical, Inc.

- Location (FDA's records): Woburn
- FDA decisions: 2 (2002–2023): 2 original PMA approvals
- Product codes: NAW (1), QVG (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P220020: Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (Apr 4, 2023)
- P990065: Sir-Spheres (Mar 5, 2002)

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