BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle

    Reg #: 3013400708 · FEI: 3013400708 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SYNAPTIC MEDICAL CORPORATION
    Registration Number
    3013400708
    FEI Number
    3013400708
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1959 Kellogg Ave
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151936

    Owner / Operator

    Firm Name
    Synaptic Medical Corp
    Operator Number
    10054312
    Address
    1959 Kellogg Ave
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198