FDA 510(k)

TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT

K-Number: K021287 · 2002-05-07

Decision Date2002-05-07

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Perfusion Systems. It received FDA 510(k) clearance on 2002-05-07 under 510(k) number K021287. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT?

TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT is a medical device that received FDA 510(k) clearance on 2002-05-07. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K021287.

When did TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT receive FDA 510(k) clearance?

TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT received FDA 510(k) clearance on 2002-05-07, under 510(k) number K021287.

Who is the listed applicant for TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT?

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

What is the FDA product code for TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT?

The FDA product code for TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT is DTN.

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Other records listing Medtronic Perfusion Systems as applicant

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Related Devices (Code: DTN)

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac Surgery K223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

Official Source

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