Cleared Traditional

CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

K102147 · Cardioquip Llp · Cardiovascular

Nov 2010

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K102147 is an FDA 510(k) clearance for the CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000, a Controller, Temperature, Cardiopulmonary Bypass (Class II — Special Controls, product code DWC), submitted by Cardioquip Llp (Bryan, US). The FDA issued a Cleared decision on November 19, 2010, 112 days after receiving the submission on July 30, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4250.

Submission Details

510(k) Number	K102147 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2010
Decision Date	November 19, 2010
Days to Decision	112 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).