Heater-Cooler System 3T— 510(k) K191402

Substantially Equivalent

Livanova Deutschland, GmbH

FDA 510(k) clearance K191402 for Heater-Cooler System 3T, Substantially Equivalent on 2020-02-25. Applicant: Livanova Deutschland, GmbH.

Clearance details

Applicant: Livanova Deutschland, GmbH
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 2019-05-24
Decision date: 2020-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.