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FDA 510(k)

Affinity NT Oxygenator with Cortiva BioActive Surface

K-Number: K162016 · 2016-09-21

ApplicantMedtronic, Inc.
Decision Date2016-09-21
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Affinity NT Oxygenator with Cortiva BioActive Surface is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2016-09-21 under approval number K162016. 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 with Cortiva BioActive Surface?

Affinity NT Oxygenator with Cortiva BioActive Surface is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Medtronic, Inc.. The 510(k) number is K162016.

When was Affinity NT Oxygenator with Cortiva BioActive Surface approved by the FDA?

Affinity NT Oxygenator with Cortiva BioActive Surface received FDA 510(k) clearance on 2016-09-21, under approval number K162016.

What company makes Affinity NT Oxygenator with Cortiva BioActive Surface?

Affinity NT Oxygenator with Cortiva BioActive Surface is manufactured by Medtronic, Inc..

What is the FDA product code for Affinity NT Oxygenator with Cortiva BioActive Surface?

The FDA product code for Affinity NT Oxygenator with Cortiva BioActive Surface is DTZ.

Related Clinical Trials

NCT07547904 Clinical Performance of Bioactive Bulk-Fill in Class II Restorations RECRUITING

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Related Devices (Code: DTZ)

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium BiosurfaceMedtronic, Inc. K153295TandemLung OxygenatorCardiacassist, Inc. K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive SurfaceMedtronic, Inc. K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous ReservoirMedtronic, Inc. 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)Terumo Cardiovascular Systems Corporation 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)Terumo Cardiovascular Systems Corporation

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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