Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020856782

FEI Number

3020856782

Entity Name

HELIOS CARDIO INC.

City/State/Country

Natick, MA, US

Establishment Address

33 Strathmore Rd, Natick, MA 01760, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Helios Cardio Inc. (Owner Number: 10083222)

Owner / Operator Contact Address

11 Dellbrook Rd, Weston, MA 02493, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210331

PMA Number

N/A

All Registered Proprietary Names

CardiaMend

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2021-12-22

Official Correspondent

Susan Reilly

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Helios Cardio Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1450662	Isomedix Operations, Inc.	Libertyville, IL, US
2183620	SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)	Saint Paul, MN, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3012664855	Anteris Technologies Corporation	Eagan, MN, US
3010805634	Anteris Aus Operations Pty Ltd	Malaga Western Australia, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020856782. Last updated year: 2026. Please use registration number 3020856782 when referencing this establishment in official correspondence.