BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Symetrex LTHD Catheter and Symetrex LTHD Catheter with Sideholes

    Reg #: 2518902 · FEI: 2518902 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MEDICAL COMPONENTS INC
    Registration Number
    2518902
    FEI Number
    2518902
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1499 DELP DRIVE
    City
    HARLEYSVILLE
    State
    PA
    ZIP
    19438
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202176

    Owner / Operator

    Firm Name
    Medical Components Inc. (dba Medcomp)
    Operator Number
    2518902
    Address
    1499 Delp Drive
    City
    Harleysville
    State
    PA
    Postal Code
    19438
    Country
    US
    Correspondent
    Martina Arno

    Products

    Device Name Product Code
    Catheter, Hemodialysis, Implanted MSD

    Proprietary Names

    Symetrex LTHD Catheter and Symetrex LTHD Catheter with Sideholes

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device