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FDA 510(k)

MPS 3 Myocardial Protection System

K-Number: K200438 · 2020-06-19

ApplicantQuest Medical, Inc.
Decision Date2020-06-19
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MPS 3 Myocardial Protection System is a medical device manufactured by Quest Medical, Inc.. It received FDA 510(k) clearance on 2020-06-19 under approval number K200438. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPS 3 Myocardial Protection System?

MPS 3 Myocardial Protection System is a medical device that received FDA 510(k) clearance on 2020-06-19. It is manufactured by Quest Medical, Inc.. The 510(k) number is K200438.

When was MPS 3 Myocardial Protection System approved by the FDA?

MPS 3 Myocardial Protection System received FDA 510(k) clearance on 2020-06-19, under approval number K200438.

What company makes MPS 3 Myocardial Protection System?

MPS 3 Myocardial Protection System is manufactured by Quest Medical, Inc..

What is the FDA product code for MPS 3 Myocardial Protection System?

The FDA product code for MPS 3 Myocardial Protection System is DTR.

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Other Devices by Quest Medical, Inc.

K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets K162804Q2 Low Pressure Power Injection Extension Set K182442MiniGuard Arterial Safety Valve K173716MPS2 Myocardial Protection System Console K201984MPS 3 ND Myocardial Protection System K202672Precision Delivery Infusion Set

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Related Devices (Code: DTR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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