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FDA 510(k)

MPS2 Myocardial Protection System Console

K-Number: K173716 · 2018-10-01

ApplicantQuest Medical, Inc.
Decision Date2018-10-01
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MPS2 Myocardial Protection System Console is a medical device manufactured by Quest Medical, Inc.. It received FDA 510(k) clearance on 2018-10-01 under approval number K173716. 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 MPS2 Myocardial Protection System Console?

MPS2 Myocardial Protection System Console is a medical device that received FDA 510(k) clearance on 2018-10-01. It is manufactured by Quest Medical, Inc.. The 510(k) number is K173716.

When was MPS2 Myocardial Protection System Console approved by the FDA?

MPS2 Myocardial Protection System Console received FDA 510(k) clearance on 2018-10-01, under approval number K173716.

What company makes MPS2 Myocardial Protection System Console?

MPS2 Myocardial Protection System Console is manufactured by Quest Medical, Inc..

What is the FDA product code for MPS2 Myocardial Protection System Console?

The FDA product code for MPS2 Myocardial Protection System Console 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 K201984MPS 3 ND Myocardial Protection System K200438MPS 3 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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