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FDA 510(k)

OXY-1 System

K-Number: K223161 · 2023-02-23

ApplicantAbiomed, Inc.
Decision Date2023-02-23
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 2023-02-23 under approval number K223161. 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 2023-02-23. It is manufactured by Abiomed, Inc.. The 510(k) number is K223161.

When was OXY-1 System approved by the FDA?

OXY-1 System received FDA 510(k) clearance on 2023-02-23, under approval number K223161.

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 K200109OXY-1 System K201116Abiomed 23 Fr Sheath K222113Abiomed 14Fr Low Profile Introducer Set K221294preCARDIA Occlusion System

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Related Devices (Code: DTZ)

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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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