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FDA 510(k)

LANDMARK REBOA Catheter

K-Number: K214060 · 2022-09-19

ApplicantZien Medical Technologies, Inc.
Decision Date2022-09-19
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LANDMARK REBOA Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Zien Medical Technologies, Inc.. It received FDA 510(k) clearance on 2022-09-19 under 510(k) number K214060. 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 LANDMARK REBOA Catheter?

LANDMARK REBOA Catheter is a medical device that received FDA 510(k) clearance on 2022-09-19. The listed applicant is Zien Medical Technologies, Inc.. The 510(k) number is K214060.

When did LANDMARK REBOA Catheter receive FDA 510(k) clearance?

LANDMARK REBOA Catheter received FDA 510(k) clearance on 2022-09-19, under 510(k) number K214060.

Who is the listed applicant for LANDMARK REBOA Catheter?

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

What is the FDA product code for LANDMARK REBOA Catheter?

The FDA product code for LANDMARK REBOA Catheter is MJN.

Other records listing Zien Medical Technologies, Inc. as applicant

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.

K240915ZIEN IO Intraosseous Access System

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 DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.K210602AortaSTAT Occlusion DeviceRenalpro Medical, 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.

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