K160187

Substantially Equivalent

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

Applicant: St Jude Medical
Product code: DQK
Advisory panel: Cardiovascular
Date received: 2016-01-27
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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.