K253692
- 510(k) number
- K253692
- Device name
- AVVIGO+ Multi-Modality Guidance System
- Applicant
- Boston Scientific MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-08-21
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253692.pdf
Official FDA record: K253692
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.