EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License— 510(k) K201148

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K201148 for EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License, Substantially Equivalent on 2020-06-26. Applicant: ABBOTT MEDICAL.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2020-04-29
Decision date: 2020-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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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.