# Spectranetics (Philips)

- Location (FDA's records): Colorado Springs
- FDA decisions: 1 (1997–1997): 1 original PMA approval
- Product codes: MFA (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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P960042: Spectranetics CVX-300 Excimer Laser System & Laser Sheath (Dec 9, 1997)

Source page: https://510kreport.com/company/spectranetics-philips