K230884
- 510(k) number
- K230884
- Device name
- AVVIGO'+ Multi-Modality Guidance System
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2023-09-26
- Date received
- 2023-03-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K230884.pdf
Official FDA record: K230884
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.