BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HELIOS CARDIO INC.

    Reg #: 3020856782 · FEI: 3020856782 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HELIOS CARDIO INC.
    Registration Number
    3020856782
    FEI Number
    3020856782
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    33 Strathmore Rd
    City
    Natick
    State
    MA
    ZIP
    01760
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210331

    Owner / Operator

    Firm Name
    Helios Cardio Inc.
    Operator Number
    10083222
    Address
    11 Dellbrook Rd
    City
    Weston
    State
    MA
    Postal Code
    02493
    Country
    US
    Correspondent
    Susan Reilly

    Products

    Device Name Product Code
    Intracardiac Patch Or Pledget, Biologically Derived PSQ

    Proprietary Names

    CardiaMend

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility