AVVIGO+ Multi-Modality Guidance System— 510(k) K253692
Substantially EquivalentBoston Scientific
FDA 510(k) clearance K253692 for AVVIGO+ Multi-Modality Guidance System, Substantially Equivalent on 2026-08-21. Applicant: Boston Scientific. Device class: 2.
Summary
Boston Scientific's AVVIGO+ Multi-Modality Guidance System is filed under product code DQK, programmable diagnostic computers. The record gives no model numbers or further description.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Boston Scientific filed from Maple Grove, Minnesota. The decision came 273 calendar days after FDA received it (November 21, 2025 to August 21, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Boston Scientific
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code DQK
view allMore clearances from Boston Scientific
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.