EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM— 510(k) K134044

Substantially Equivalent

Cardio Tek, BV

FDA 510(k) clearance K134044 for EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM, Substantially Equivalent on 2014-03-31. Applicant: Cardio Tek, BV.

Clearance details

Applicant: Cardio Tek, BV
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2013-12-31
Decision date: 2014-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballwin, MO, 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.