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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 a medical device manufactured by Zien Medical Technologies, Inc.. It received FDA 510(k) clearance on 2022-09-19 under approval 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. It is manufactured by Zien Medical Technologies, Inc.. The 510(k) number is K214060.

When was LANDMARK REBOA Catheter approved by the FDA?

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

What company makes LANDMARK REBOA Catheter?

LANDMARK REBOA Catheter is manufactured by Zien Medical Technologies, Inc..

What is the FDA product code for LANDMARK REBOA Catheter?

The FDA product code for LANDMARK REBOA Catheter is MJN.

Other Devices by Zien Medical Technologies, Inc.

K240915ZIEN IO Intraosseous Access System

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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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