BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TSI Transseptal Introducer

    Reg #: 3013986346 · FEI: 3013986346 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Registration Number
    3013986346
    FEI Number
    3013986346
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 School Street
    City
    Morton
    State
    PA
    ZIP
    19070
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181031

    Owner / Operator

    Firm Name
    Pressure Products Medical Device Manufacturing LLC
    Operator Number
    10052778
    Address
    1 School Street
    City
    Morton
    State
    PA
    Postal Code
    19070
    Country
    US
    Correspondent
    Andrew W Armour

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    TSI Transseptal Introducer

    Establishment Types

    Manufacture Medical Device