AVVIGO'+ Multi-Modality Guidance System
FDA 510(k) clearance K230884 · decided 2023-09-26
Clearance details
- K-number
- K230884
- Device name
- AVVIGO'+ Multi-Modality Guidance System
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-03-30
- Decision date
- 2023-09-26
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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