BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDICAL COMPONENTS INC

    Reg #: 2518902 · FEI: 2518902 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    4
    Establishment Types
    7
    Classifications
    34

    Registration Details

    Registration Name
    MEDICAL COMPONENTS INC
    Registration Number
    2518902
    FEI Number
    2518902
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1499 DELP DRIVE
    City
    HARLEYSVILLE
    State
    PA
    ZIP
    19438
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091953

    Owner / Operator

    Firm Name
    Medical Components Inc
    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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Catheter, Hemodialysis, Implanted MSD
    Catheter, Peritoneal, Long-Term Indwelling FJS
    Midline Catheter PND
    Introducer, Catheter DYB
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Device, Intravascular Catheter Securement KMK
    Catheter, Hemodialysis, Triple Lumen, Non-Implanted NIE
    Catheter, Hemodialysis, Non-Implanted MPB
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Graft, Vascular, Stainless Steel Tunneler MZY
    Saline, Vascular Access Flush NGT
    Catheter, Percutaneous DQY
    Wire, Guide, Catheter DQX
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Instruments, Surgical, Cardiovascular DWS
    Stylet, Surgical, General & Plastic Surgery GAH
    Non-Coring (Huber) Needle PTI
    Catheter, Subclavian LFJ
    Accessories, A-V Shunt KNZ
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Irrigation GBX
    Catheter, Femoral LFK
    Kit, Repair, Catheter, Hemodialysis NFK
    Clamp HXD
    Set, Administration, Intravascular FPA
    Catheter, Infusion JCY
    Needle, Catheter GCB
    Syringe, Piston FMF
    Guide, Needle, Surgical GDF
    Trocar DRC
    Tubes, Gastrointestinal (And Accessories) KNT
    Clamp, Vascular DXC
    Catheter, Ventricular, General & Plastic Surgery GBS

    Proprietary Names

    Pro-PICC(R) CT Symetrex LTHD Catheter and Symetrex LTHD Catheter with Sideholes 20G X 3/4" Pro-Lock Safety Infusion Set Duralock

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Reprocess Single-Use Device