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FDA 510(k)

Affinity Fusion™ Oxygenator System

K-Number: K230640 · 2023-04-06

ApplicantMedtronic, Inc.
Decision Date2023-04-06
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Affinity Fusion™ Oxygenator System is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2023-04-06 under approval number K230640. 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 Fusion™ Oxygenator System?

Affinity Fusion™ Oxygenator System is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by Medtronic, Inc.. The 510(k) number is K230640.

When was Affinity Fusion™ Oxygenator System approved by the FDA?

Affinity Fusion™ Oxygenator System received FDA 510(k) clearance on 2023-04-06, under approval number K230640.

What company makes Affinity Fusion™ Oxygenator System?

Affinity Fusion™ Oxygenator System is manufactured by Medtronic, Inc..

What is the FDA product code for Affinity Fusion™ Oxygenator System?

The FDA product code for Affinity Fusion™ Oxygenator System is DTZ.

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Other Devices by Medtronic, Inc.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162054Medtronic Temporary External Pacemaker 53401 K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement

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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. 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

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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