K252945
- 510(k) number
- K252945
- Device name
- Novasight Hybrid System
- Applicant
- Conavi Medical, Inc. CA
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2026-04-17
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252945.pdf
Official FDA record: K252945
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.