BEUDAMED
    FDA Registration Active 🇮🇱 Israel

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    Reg #: 3030471525 · FEI: 3030471525 · Expires 2025
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    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PI-CARDIA LTD
    Registration Number
    3030471525
    FEI Number
    3030471525
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    David Fikes 5
    City
    Rehovot Central
    Country
    IL

    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 Manufacture Medical Device