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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 the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) 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. The listed applicant is Abiomed, Inc.. The 510(k) number is K221294.

When did preCARDIA Occlusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for preCARDIA Occlusion System?

The FDA 510(k) record lists Abiomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for preCARDIA Occlusion System?

The FDA product code for preCARDIA Occlusion System is MJN.

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Related Devices (Code: MJN)

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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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