EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2— 510(k) K182644

Substantially Equivalent

Abbott

FDA 510(k) clearance K182644 for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2, Substantially Equivalent on 2018-10-19. Applicant: Abbott.

Clearance details

Applicant: Abbott
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2018-09-24
Decision date: 2018-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, 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.