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FDA 510(k)

preCARDIA Occlusion System

K-Number: K221294 · 2023-06-30

ApplicantAbiomed, Inc.
Decision Date2023-06-30
Product CodeMJN
Advisory CommitteeCV
DecisionUnknown

Device Summary

preCARDIA Occlusion System is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2023-06-30 under approval number K221294. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the preCARDIA Occlusion System?

preCARDIA Occlusion System is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Abiomed, Inc.. The 510(k) number is K221294.

When was preCARDIA Occlusion System approved by the FDA?

preCARDIA Occlusion System received FDA 510(k) clearance on 2023-06-30, under approval number K221294.

What company makes preCARDIA Occlusion System?

preCARDIA Occlusion System is manufactured by Abiomed, Inc..

What is the FDA product code for preCARDIA Occlusion System?

The FDA product code for preCARDIA Occlusion System is MJN.

Related Clinical Trials

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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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