Cleared Traditional

Heater-Cooler System 3T

K191402 · Livanova Deutschland, GmbH · Cardiovascular

Feb 2020

Decision

277d

Days

Class 2

Risk

About This 510(k) Submission

K191402 is an FDA 510(k) clearance for the Heater-Cooler System 3T, a Controller, Temperature, Cardiopulmonary Bypass (Class II — Special Controls, product code DWC), submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on February 25, 2020, 277 days after receiving the submission on May 24, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4250.

Submission Details

510(k) Number	K191402 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2019
Decision Date	February 25, 2020
Days to Decision	277 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWC — Controller, Temperature, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4250
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).