Cleared Traditional

HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM

K122813 · Cincinnati Sub-Zero Products, Inc. · Cardiovascular

Dec 2012

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K122813 is an FDA 510(k) clearance for the HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM, a Controller, Temperature, Cardiopulmonary Bypass (Class II — Special Controls, product code DWC), submitted by Cincinnati Sub-Zero Products, Inc. (Sharonville, US). The FDA issued a Cleared decision on December 18, 2012, 96 days after receiving the submission on September 13, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4250.

Submission Details

510(k) Number	K122813 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2012
Decision Date	December 18, 2012
Days to Decision	96 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).