K243884
- 510(k) number
- K243884
- Device name
- TAVIPILOT
- Applicant
- Caranx Medical FR
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-07-07
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243884.pdf
Official FDA record: K243884
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.