EP-TRACER System— 510(k) K161245

Substantially Equivalent

Cardio Tek, BV

FDA 510(k) clearance K161245 for EP-TRACER System, Substantially Equivalent on 2016-08-05. Applicant: Cardio Tek, BV.

Clearance details

Applicant: Cardio Tek, BV
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2016-05-03
Decision date: 2016-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ae Maastricht-Airport Limburg, NL

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.