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FDA 510(k)

AortaSTAT Occlusion Device

K-Number: K210602 · 2021-07-09

ApplicantRenalpro Medical, Inc.
Decision Date2021-07-09
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AortaSTAT Occlusion Device is a medical device manufactured by Renalpro Medical, Inc.. It received FDA 510(k) clearance on 2021-07-09 under approval number K210602. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AortaSTAT Occlusion Device?

AortaSTAT Occlusion Device is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by Renalpro Medical, Inc.. The 510(k) number is K210602.

When was AortaSTAT Occlusion Device approved by the FDA?

AortaSTAT Occlusion Device received FDA 510(k) clearance on 2021-07-09, under approval number K210602.

What company makes AortaSTAT Occlusion Device?

AortaSTAT Occlusion Device is manufactured by Renalpro Medical, Inc..

What is the FDA product code for AortaSTAT Occlusion Device?

The FDA product code for AortaSTAT Occlusion Device 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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