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FDA 510(k)

TandemLung Oxygenator

K-Number: K153295 · 2016-02-26

ApplicantCardiacassist, Inc.
Decision Date2016-02-26
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TandemLung Oxygenator is a medical device manufactured by Cardiacassist, Inc.. It received FDA 510(k) clearance on 2016-02-26 under approval number K153295. 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 TandemLung Oxygenator?

TandemLung Oxygenator is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Cardiacassist, Inc.. The 510(k) number is K153295.

When was TandemLung Oxygenator approved by the FDA?

TandemLung Oxygenator received FDA 510(k) clearance on 2016-02-26, under approval number K153295.

What company makes TandemLung Oxygenator?

TandemLung Oxygenator is manufactured by Cardiacassist, Inc..

What is the FDA product code for TandemLung Oxygenator?

The FDA product code for TandemLung Oxygenator is DTZ.

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Related Devices (Code: DTZ)

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium BiosurfaceMedtronic, Inc. K162016Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, 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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