K253692

AVVIGO™+ Multi-Modality Guidance System

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.