BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC

    Reg #: 3013986346 · FEI: 3013986346 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Registration Number
    3013986346
    FEI Number
    3013986346
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 School Street
    City
    Morton
    State
    PA
    ZIP
    19070
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221707

    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
    Trocar DRC
    Introducer, Catheter DYB
    Catheter, Septostomy DXF

    Proprietary Names

    SafeSept Transseptal Guidewire SafeSept Needle Free Transseptal Guidewire TSN Transseptal Needle TSI Transseptal Introducer Needle Free Transseptal Cannula SafeSharp Transseptal Needle SafeSept RF Transseptal Guidewire SafeSept Blunt Needle

    Establishment Types

    Manufacture Medical Device