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K Number
K102147
Device Name
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
Manufacturer
CARDIOQUIP LLP
Date Cleared
2010-11-19

(112 days)

Product Code
DWC
Regulation Number
870.4250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text only contains an FDA 510(k) clearance letter for the CardioQuip Modular Cooler-Heater (MCH). This document does not contain any information about acceptance criteria, study details, or performance data of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the given text.

The document primarily focuses on:

  • Confirming the substantial equivalence of the CardioQuip MCH to a legally marketed predicate device.
  • Outlining regulatory requirements and guidance for the manufacturer (CardioQuip, LLP).
  • Stating the intended "Indications For Use" for the CardioQuip MCH.

§ 870.4250 Cardiopulmonary bypass temperature controller.

(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).