← Product Code MFA · P960042

# SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH (P960042)

_Spectranetics (Philips) · MFA · Dec 9, 1997 · Cardiovascular · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P960042

## Device Facts

- **Applicant:** Spectranetics (Philips)
- **Product Code:** MFA
- **Decision Date:** Dec 9, 1997
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular
- **Attributes:** Expedited Review

---

**Source:** [https://fda.innolitics.com/device/P960042](https://fda.innolitics.com/device/P960042)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
