Heater-Cooler System 3T
K-Number: K191402 · 2020-02-25
ApplicantLivanova Deutschland, GmbH
Decision Date2020-02-25
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Heater-Cooler System 3T is a medical device manufactured by Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2020-02-25 under approval number K191402. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Heater-Cooler System 3T?
Heater-Cooler System 3T is a medical device that received FDA 510(k) clearance on 2020-02-25. It is manufactured by Livanova Deutschland, GmbH. The 510(k) number is K191402.
When was Heater-Cooler System 3T approved by the FDA?
Heater-Cooler System 3T received FDA 510(k) clearance on 2020-02-25, under approval number K191402.
What company makes Heater-Cooler System 3T?
Heater-Cooler System 3T is manufactured by Livanova Deutschland, GmbH.
What is the FDA product code for Heater-Cooler System 3T?
The FDA product code for Heater-Cooler System 3T is DWC.
Related Clinical Trials
Other Devices by Livanova Deutschland, GmbH
Related Devices (Code: DWC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.