K250310
- 510(k) number
- K250310
- Device name
- VIKING Fixed Curve Diagnostic Catheter
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DRF — Catheter, Electrode Recording, Or Probe, Electrode R
- Decision date
- 2025-06-27
- Date received
- 2025-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250310.pdf
Official FDA record: K250310
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.