CardiaMend Pericardial and Epicardial Reconstruction Matrix— 510(k) K210331

Name: FDA 510(k) clearance K210331
Creator: U.S. Food and Drug Administration
Published: 2021-12-21

Substantially Equivalent

Helios Cardio, Inc.

FDA 510(k) clearance K210331 for CardiaMend Pericardial and Epicardial Reconstruction Matrix, Substantially Equivalent on 2021-12-21. Applicant: Helios Cardio, Inc.. Device class: 2.

Clearance details

Applicant: Helios Cardio, Inc.
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2021-02-05
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.