K251344
- 510(k) number
- K251344
- Device name
- OptiMap System
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-05-28
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251344.pdf
Official FDA record: K251344
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.