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MPS Myocardial Protection System - MPS 2 Console, Model 5201260

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041979

by Quest Medical Inc

Identifiers

510(k) Number
K041979 FDA 510(k)
FDA Product Code
DTR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4240 FDA 510(k)
Regulation Number
870.4240 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MPS Myocardial Protection System - MPS 2 Console, Model 5201260 is a heat-exchanger device used in cardiopulmonary bypass procedures. It is classified as a Class II medical device and is substantially equivalent to a predicate device under FDA 510(k) clearance K041979.

The device is supplied by Quest Medical Inc. and is intended for use in cardiovascular applications. It is regulated under FDA product code DTR and regulation number 870.4240, with multiple facility registrations and listings on file.

Frequently asked questions

What is the MPS Myocardial Protection System MPS 2 Console Model 5201260 used for?

It is a heat-exchanger device used in cardiopulmonary bypass procedures to regulate temperature during cardiovascular surgery, helping protect the myocardium by managing blood temperature as part of the extracorporeal circuit.

Is the MPS 2 Console Model 5201260 a single-use or reusable device?

The device data does not specify whether the MPS 2 Console Model 5201260 is single-use or reusable; however, as a heat-exchanger console, it is typically designed for repeated use with disposable tubing sets, though reuse protocols would depend on manufacturer instructions and institutional policies.

What regulatory pathway was used for the MPS 2 Console Model 5201260?

The device received FDA 510(k) clearance under K041979, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device under product code DTR and regulation 870.4240.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quest Medical Inc
FDA Applicant
Quest Medical, Inc.

Sources (1)

  • FDA 510(k) K041979 24 fields · synced Sep 21, 2026