FDA 510(k)

Quantum Pump Console

K-Number: K173834 · 2018-05-25

Decision Date2018-05-25

Product CodeDTQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Quantum Pump Console is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2018-05-25 under approval number K173834. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Pump Console?

Quantum Pump Console is a medical device that received FDA 510(k) clearance on 2018-05-25. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K173834.

When was Quantum Pump Console approved by the FDA?

Quantum Pump Console received FDA 510(k) clearance on 2018-05-25, under approval number K173834.

What company makes Quantum Pump Console?

Quantum Pump Console is manufactured by Spectrum Medical , Ltd..

What is the FDA product code for Quantum Pump Console?

The FDA product code for Quantum Pump Console is DTQ.

Other Devices by Spectrum Medical , Ltd.

K163657Quantum Workstation K181942Quantum Ventilation Module K181923Quantum Workstation 12.1 K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) K202733Quantum Ventilation Module

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Related Devices (Code: DTQ)

K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation K163531Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd. K210130Stockert S5 SystemLivanova Deutschland, GmbH K202125Century Perfusion SystemCentury Hlm, LLC K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH

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.