BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ANGIODYNAMICS, INC.

    Reg #: 1319211 · FEI: 1319211 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    82
    Establishment Types
    3
    Classifications
    24

    Registration Details

    Registration Name
    ANGIODYNAMICS, INC.
    Registration Number
    1319211
    FEI Number
    1319211
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    603 QUEENSBURY AVE.
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032557

    Owner / Operator

    Firm Name
    ANGIODYNAMICS, INC
    Operator Number
    9028212
    Address
    26 Forest St., --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Catheter, Continuous Flush KRA
    Mechanical Thrombolysis Catheter QEY
    Set, Administration, Intravascular FPA
    Wire, Guide, Catheter DQX
    Trocar DRC
    Cannula, Catheter DQR
    Introducer, Catheter DYB
    Aspiration Thrombectomy Catheter QEZ
    Powered Laser Surgical Instrument GEX
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Irrigation GBX
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Needle, Hypodermic, Single Lumen FMI
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Low Energy Direct Current Thermal Ablation System OAB
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Tubing, Pump, Cardiopulmonary Bypass DWE
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Midline Catheter PND

    Proprietary Names

    Vortex TR Vascular Access Port LifeValve Platinum Kit Uni-Fuse+ Infusion System LifeGuard Vision Safety Infusion Set LifeGuard Infusion Set Xcela Plus Port with PASV Valve Technology BioFlo Port with ENDEXO Technology BioFlo Port with ENDEXO and PASV Valve Technology Xcela Plus Port Micro Access and Micro Introducers NMI Dual Port II AlphaVac Multipurpose Mechanical Aspiration (MMA) System VenaCure NeverTouch Procedure Kits Soft-Vu, Mariner, AngiOPtic, Accu-Vu, Angiographic Catheters Total Abscession General Drainage Catheters BioFlo Midline with ENDEXO Technology AlphaVac MMA F1885 System VenaCure EVLT NeverTouch-FRS LifePort Vascular Access Port Vortex LP Vascular Access Port AngioVac 16 Gauge Entry Needle AlphaVac Multipurpose Mechanical Aspiration System F1885 VenaCure EVLT 400mm Perorator and Accessory Vein Ablation Kit BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY Mini Stick ENVI Non-Vascular Introducer Kit C3 Wave System Soft-Vu Angiographic Catheters Mariner Angiographic Catheters SmartPort+ SmartPort Plastic D30 Plus Laser System EVLT Kit D15 Plus Laser System Total Abscession Biliary Drainage Catheter Smart Port CT SpeedLyser Infusion Catheter Kit NanoKnife VenaCure EVLT NeverTouch Procedure Kit EXODUS BELIEVE BILIARY DRAINAGE CATHETER EXODUS NUANCE NEPHROSTOMY DRAINAGE CATHETER EXODUS ARRAY MULTIPURPOSE DRAINAGE CATHETER Xcela Power Injectable PICC Xcela Hybrid PICC with PASV Valve Technology BioFlo PICC wth ENDEXO Technology Xcela PICC with PASV Valve Technology BioFlo PICC wth ENDEXO and PASV Valve Technology BioFlo Hybrid PICC wth ENDEXO and PASV Valve Technology Total Abscession Nephrostomy Drainage Catheter VenaCure EVLT Nevertouch Procedure Kits Pulse Spray Infusion System UniFuse Infusion System Triumph-1 Vascular Access Port Canister AngioVac Cannula Vortex MP Vascular Access Port BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY XCELA POWER INJECTABLE PICC BIOFLO PICC WITH ENDEXO TECHNOLOGY PASV MS Kit with Pressure Activated Safety Valve LifePort Infusion Set AlphaVac Multipurpose Mechanical Aspiration (MMA) System F18 85 Celerity Vortex VX Vascular Access Port AngioVac Circuit Pack VenaCure EVLT NeverTouch Direct Introducer Sheath Mariner Hydrophilic Angiographic Catheters AngiOptic Angiographic Catheters Accu-Vu Sizing Catheters Smart Port CT Low-Profile Smart Port CT Mini BIOFLO PORT WITH ENDEXO AND PASV VALVE TECHNOLOGY BIOFLO PORT WITH ENDEXO TECHNOLOGY VAXCEL MINI STICK KIT MINI STICK MAX COAXIAL MICROINTRODUCER KIT NAVILYST MEDICAL PICC CONVENIENCE KIT VenaCure EVLT NeverTouch VenaCure EVLT Tre-Sheath Xcela Power Injectable PICC Maximal Barrier Nursing Kit BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit BioFlo PICC with ENDEXO Technology-Maximal Barrier Nursing Kit BioFlo PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198