FDA 510(k)

AortaSTAT Occlusion Device

K-Number: K210602 · 2021-07-09

Decision Date2021-07-09

Product CodeMJN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AortaSTAT Occlusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Renalpro Medical, Inc.. It received FDA 510(k) clearance on 2021-07-09 under 510(k) 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. The listed applicant is Renalpro Medical, Inc.. The 510(k) number is K210602.

When did AortaSTAT Occlusion Device receive FDA 510(k) clearance?

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

Who is the listed applicant for AortaSTAT Occlusion Device?

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

What is the FDA product code for AortaSTAT Occlusion Device?

The FDA product code for AortaSTAT Occlusion Device is MJN.

Related Devices (Code: MJN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices K221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC K212324RenovoCathRenovorx, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.