Heater-Cooler System 3T— 510(k) K220635

Name: FDA 510(k) clearance K220635
Creator: U.S. Food and Drug Administration
Published: 2022-11-16

Substantially Equivalent

Livanova Deutschland, GmbH

FDA 510(k) clearance K220635 for Heater-Cooler System 3T, Substantially Equivalent on 2022-11-16. Applicant: Livanova Deutschland, GmbH. Device class: 2.

Clearance details

Applicant: Livanova Deutschland, GmbH
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 2022-03-04
Decision date: 2022-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munchen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWC

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K212657 — Quantum Heater-Cooler2022-05-06
K191402 — Heater-Cooler System 3T2020-02-25
K140012 — SORIN FLEXTHERM2014-01-31
K130300 — HEATER-COOLER UNIT HCU 402013-07-01
K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM2012-12-18

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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.