K252302
- 510(k) number
- K252302
- Device name
- CARTO 3 EP Navigation System V8.1
- Applicant
- Biosense Webster, Inc. CA · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-08-22
- Date received
- 2025-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252302.pdf
Official FDA record: K252302
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.