Cleared Traditional

HEATER-COOLER UNIT HCU 40

K130300 · Maquet Cardiopulmonary, AG · Cardiovascular

Jul 2013

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K130300 is an FDA 510(k) clearance for the HEATER-COOLER UNIT HCU 40, a Controller, Temperature, Cardiopulmonary Bypass (Class II — Special Controls, product code DWC), submitted by Maquet Cardiopulmonary, AG (Wayne, US). The FDA issued a Cleared decision on July 1, 2013, 144 days after receiving the submission on February 7, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4250.

Submission Details

510(k) Number	K130300 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2013
Decision Date	July 01, 2013
Days to Decision	144 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).