510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K210331Substantially Equivalent

CardiaMend Pericardial and Epicardial Reconstruction Matrix

Helios Cardio Inc., Weston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210331 is the FDA 510(k) clearance record for CardiaMend Pericardial and Epicardial Reconstruction Matrix, a class II device, cleared for Helios Cardio, Inc. on under FDA product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived). FDA's definition for product code PSQ reads: "To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature". FDA records list one 510(k) clearance for Helios Cardio, Inc. As of , FDA records show no recalls naming K210331.

Clearance record

Decision date
Received
(319 days to decision)
Product code
PSQ Intracardiac Patch Or Pledget, Biologically Derived
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Helios Cardio, Inc. 11 Dellbrook Rd., Weston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSQ

Trailing 12 months

FDA records hold no clearances under product code PSQ in the trailing twelve months.

FDA records show no clearances under product code PSQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PSQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260