Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0— 510(k) K160187

Name: FDA 510(k) clearance K160187
Creator: U.S. Food and Drug Administration
Published: 2016-10-21

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K160187 for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0, Substantially Equivalent on 2016-10-21. Applicant: St Jude Medical. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2016-01-27
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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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.