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510(k) K210331

CardiaMend Pericardial and Epicardial Reconstruction Matrix by Helios Cardio, Inc. — Product Code PSQ

K210331 is an FDA 510(k) premarket notification submitted by Helios Cardio, Inc. for the device "CardiaMend Pericardial and Epicardial Reconstruction Matrix". The FDA issued a decision of Substantially Equivalent on December 21, 2021. The device falls under product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived), a Class II device regulated under 21 CFR 870.3470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2021
Date Received
February 5, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracardiac Patch Or Pledget, Biologically Derived
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

Other clearances for product code PSQ

  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K200566 — ADAPT Tissue (April 3, 2020)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K183635 — PhotoFix Decellularized Bovine Pericardium (February 14, 2019)
  • K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm (October 10, 2018)
  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K172660 — Duravess bovine pericardial vascular patch (November 17, 2017)
  • K170951 — CardioCel 3D (April 28, 2017)

FDA data resources