AVVIGO Guidance System— 510(k) K201713

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K201713 for AVVIGO Guidance System, Substantially Equivalent on 2020-07-23. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2020-06-23
Decision date: 2020-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.