K-number	K210331
Device name	CardiaMend Pericardial and Epicardial Reconstruction Matrix
Applicant	Helios Cardio, Inc.
Product code	PSQ
Device class	Class II
Decision date	Dec 21, 2021
Decision	Substantially Equivalent
Regulation	870.3470

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Source

View the full FDA submission: accessdata.fda.gov

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CardiaMend Pericardial and Epicardial Reconstruction Matrix

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