BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ShortCut

    Reg #: 3033307537 · FEI: 3033307537 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pi-Cardia Inc
    Registration Number
    3033307537
    FEI Number
    3033307537
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 Broadway Ct
    City
    Cambridge
    State
    MA
    ZIP
    02138
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240017

    Owner / Operator

    Firm Name
    Pi-Cardia LtD
    Operator Number
    10091623
    Address
    David Fikes 5
    City
    Rehovot
    State
    Central
    Postal Code
    7632805
    Country
    IL
    Correspondent
    Hadas Givon

    Products

    Device Name Product Code
    Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures SCZ

    Proprietary Names

    ShortCut

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198