K254085
- 510(k) number
- K254085
- Device name
- CARTO 3 EP Navigation System V9.0 with PIU Plus
- Applicant
- Biosense Webster, Inc. CA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-01-18
- Date received
- 2025-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254085.pdf
Official FDA record: K254085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.