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FDA 510(k)

Advanced Perfusion System 1

K-Number: K172220 · 2017-08-17

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2017-08-17
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advanced Perfusion System 1 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K172220. 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 2017-08-17. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K172220.

When did Advanced Perfusion System 1 receive FDA 510(k) clearance?

Advanced Perfusion System 1 received FDA 510(k) clearance on 2017-08-17, under 510(k) number K172220.

Who is the listed applicant for Advanced Perfusion System 1?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Terumo Cardiovascular Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234065CDI OneView Monitoring SystemK221895Terumo Advanced Perfusion System 1K200091Capiox iCP Centrifugal PumpK182110CDI Blood Parameter Monitoring System 550K180950Terumo 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)

View all 10 devices →

Related Devices (Code: DTQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

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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