EP-TRACER System— 510(k) K183266

Substantially Equivalent

Schwarzer Cardiotek GmbH

FDA 510(k) clearance K183266 for EP-TRACER System, Substantially Equivalent on 2019-03-01. Applicant: Schwarzer Cardiotek GmbH.

Clearance details

Applicant: Schwarzer Cardiotek GmbH
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2018-11-23
Decision date: 2019-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Heilbronn, DE

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.