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FDA 510(k)

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface

K-Number: K162896 · 2016-12-06

ApplicantMedtronic, Inc.
Decision Date2016-12-06
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K162896. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface?

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Medtronic, Inc.. The 510(k) number is K162896.

When did Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface receive FDA 510(k) clearance?

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface received FDA 510(k) clearance on 2016-12-06, under 510(k) number K162896.

Who is the listed applicant for Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface?

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

What is the FDA product code for Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface?

The FDA product code for Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface is DTZ.

Related Clinical Trials

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.

NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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Related Devices (Code: DTZ)

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.

K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.LK240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)Medtronic Perfusion Systems

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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