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FDA 510(k)

Advanced Perfusion System 1

K-Number: K163531 · 2017-06-07

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2017-06-07
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advanced Perfusion System 1 is a medical device manufactured by Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2017-06-07 under approval number K163531. 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 Advanced Perfusion System 1?

Advanced Perfusion System 1 is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Terumo Cardiovascular Systems Corporation. The 510(k) number is K163531.

When was Advanced Perfusion System 1 approved by the FDA?

Advanced Perfusion System 1 received FDA 510(k) clearance on 2017-06-07, under approval number K163531.

What company makes Advanced Perfusion System 1?

Advanced Perfusion System 1 is manufactured by Terumo Cardiovascular Systems Corporation.

What is the FDA product code for Advanced Perfusion System 1?

The FDA product code for Advanced Perfusion System 1 is DTQ.

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Related PubMed Literature

PMID: 41524152 Securing data management systems in perfusion: A narrative review on cybersecurity and clinical risk. Perfusion (2026)

Other Devices by Terumo Cardiovascular Systems Corporation

K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 K160206VirtuoSaph Plus Endoscopic Vessel Harvesting System K172220Advanced Perfusion System 1 K182110CDI Blood Parameter Monitoring System 550 K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)

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Related Devices (Code: DTQ)

K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation K173834Quantum Pump ConsoleSpectrum Medical , Ltd. 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.

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