K251463

Substantially Equivalent

EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)

Applicant: ABBOTT MEDICAL
Product code: DQK
Advisory panel: Cardiovascular
Date received: 2025-05-12
Decision date: 2025-09-04
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.