BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GAMAMED VASCULAR SYSTEMS INC.

    Reg #: 3035111606 · FEI: 3035111606 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    41
    Establishment Types
    2
    Classifications
    22

    Registration Details

    Registration Name
    GAMAMED VASCULAR SYSTEMS INC.
    Registration Number
    3035111606
    FEI Number
    3035111606
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    815 14Th Street SW, Suite C250
    City
    Loveland
    State
    CO
    ZIP
    80537
    Country
    US

    Regulatory Submissions

    510(k) Number
    K973477

    Owner / Operator

    Firm Name
    Gamamed Vascular Systems Inc.
    Operator Number
    10092344
    Address
    815 14Th Street SW, Suite C250
    City
    Loveland
    State
    CO
    Postal Code
    80537
    Country
    US
    Correspondent
    Lorena Arrieche

    Products

    Device Name Product Code
    Catheter, Embolectomy DXE
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Gas-Machine, Anesthesia BSZ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter DQA
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Table, Operating-Room, Ac-Powered FQO
    Lamp, Operating-Room FQP
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Catheter, Hemodialysis, Non-Implanted MPB
    Catheter, Hemodialysis, Implanted MSD
    Electrode, Pacemaker, Temporary LDF
    Introducer, Catheter DYB
    Syringe, Piston FMF
    Syringe, Antistick MEG
    Needle, Hypodermic, Single Lumen FMI
    Set, Administration, Intravascular FPA
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Umbilical Artery FOS
    Catheter, Percutaneous DQY

    Proprietary Names

    Clear Embolectomy Catheter ENERGY-CT-PICC Peripherally Inserted Central Catheter (PICC), single, double and triple lumen Atlantis Pro Anesthesia Machine Volta Pro Anesthesia Machine Atlantis Anesthesia Machine Volta Anesthesia Machine Aspen Pro Patient Monitor Aspen Patient Monitor Eve Pro Operation Table Eve Operation Table Gina Operation Table Vail Surgical Lamp 700/700 Vail Mobile Surgical Lamp 520 Vail Mobile Surgical Lamp 720/720 Vail Surgical Lamp 700 Vail Mobile Surgical Lamp 700 Vail Mobile Surgical Lamp 500 Vail Surgical Lamp 500 Vail Mobile Surgical Lamp 720 Vail Surgical Lamp 700/500 Vail Mobile Surgical Lamp 720/520 Lotus Central Venous Catheter Orbic Hemodialysis Catheter Twinflow Pediatric HC Vigor Bipolar Pacing Catheter Swift Peripheral IV Catheter Colorado Introducer Sheath Access Sets Veinglide Midline Catheter Energy CT Midline Catheter Mini Veinglide Mini Midline Catheter Dialycath Peritoneal Dialysis Catheter HOG Luer Lock Syringe Energy PICC CT Peripherally Inserted Central Catheter Precision Flow Long Term Hemodialysis Catheter Mercury IV Administration Sets Flexivacath Closed Safety IV Catheter System Alfa Central Venous Catheter Sets Force CT Central Venous Catheter Inter Semi-Compliant PTCA Balloon Dilatation Catheter Umbilicath Umbilical Catheter Arterioglide Arterial Catheter

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device