K-number	K214060
Device name	LANDMARK REBOA Catheter
Applicant	Zien Medical Technologies, Inc.
Product code	MJN
Device class	Class II
Decision date	Sep 19, 2022
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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LANDMARK REBOA Catheter

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