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FDA 510(k)

OXY-1 System

K-Number: K200109 · 2020-10-23

ApplicantAbiomed, Inc.
Decision Date2020-10-23
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXY-1 System is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2020-10-23 under approval number K200109. 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 OXY-1 System?

OXY-1 System is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Abiomed, Inc.. The 510(k) number is K200109.

When was OXY-1 System approved by the FDA?

OXY-1 System received FDA 510(k) clearance on 2020-10-23, under approval number K200109.

What company makes OXY-1 System?

OXY-1 System is manufactured by Abiomed, Inc..

What is the FDA product code for OXY-1 System?

The FDA product code for OXY-1 System is DTZ.

Other Devices by Abiomed, Inc.

K192769Impella CP Introducer K202330Impella XR Sheath Set K201116Abiomed 23 Fr Sheath K222113Abiomed 14Fr Low Profile Introducer Set K221294preCARDIA Occlusion System K223161OXY-1 System

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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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