BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPECTRUM VASCULAR

    Reg #: 3030714660 · FEI: 3030714660 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    29
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    SPECTRUM VASCULAR
    Registration Number
    3030714660
    FEI Number
    3030714660
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50 Main St. Suite 1000
    City
    White Plains
    State
    NY
    ZIP
    10606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121990

    Owner / Operator

    Firm Name
    Spectrum Vascular
    Operator Number
    10090343
    Address
    50 Main St. Suite 1000
    City
    White Plains
    State
    NY
    Postal Code
    10606
    Country
    US
    Correspondent
    Sharon Klugewicz

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Midline Catheter PND
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Needle, Hypodermic, Single Lumen FMI
    Catheter, Embolectomy DXE
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) NHC
    Catheter, Intravascular, Diagnostic DQO

    Proprietary Names

    Navilyst Medical PICC Convenience Kit BioFlo PICC with ENDEXO and PASV Valve Technology - Maximal Barrier Nursing Kit BioFlo PICC with ENDEXO Technology - Maximal Barrier Nursing Kit BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit Xcela Power Injectable PICC Maximal Barrier Nursing Kit BioFlo Midline with ENDEXO Technology Intraosseous Infusion Needle XCELA POWER INJECTABLE PICC BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY BIOFLO PICC WITH ENDEXO TECHNOLOGY BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY Bunegin-Albin Air Aspiration Set SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING SPECTRUM SILICONE CATHETER C3 Wave System BioFlo PICC with Endexo and PASV Valve Technology XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY XCELA PICC WITH PASV VALVE TECHNOLOGY BIOFLO MIDLINE CATHETER Spectrum Vascular Intraosseous Infusion Needles PASV MS Kit with Pressure Activated Safety Valve Spectrum Vascular Unimpregnated Central Venous Catheter Celerity VentriClear II Ventricular Drainage Catheter VentriClear Ventricular Drainage Catheter Set with Spectrum Antibiotic Impregnation Arterial Pressure Monitoring Set/Tray XCELA Hybrid PICC with PASV Valve Technology XCELA PICC with PASV Valve Technology SPECTRUM CENTRAL VENOUS CATHETERS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device