Heater-Cooler System 3T
K-Number: K220635 · 2022-11-16
ApplicantLivanova Deutschland, GmbH
Decision Date2022-11-16
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 2022-11-16 under approval number K220635. 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 2022-11-16. It is manufactured by Livanova Deutschland, GmbH. The 510(k) number is K220635.
When was Heater-Cooler System 3T approved by the FDA?
Heater-Cooler System 3T received FDA 510(k) clearance on 2022-11-16, under approval number K220635.
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.