FDA Registration Active 🇺🇸 United States

AngioDynamics, Inc.

Reg #: 1000523114 · FEI: 1000523114 · Expires 2026
Products
26
Proprietary Names
85
Establishment Types
1
Classifications
26

Registration Details

Registration Name
AngioDynamics, Inc.
Registration Number
1000523114
FEI Number
1000523114
Status
Active
Expiry Year
2026
Initial Importer
No
Address
26 Forest St
City
Marlborough
State
MA
ZIP
01752
Country
US

Regulatory Submissions

510(k) Number
K163356

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
Catheter, Continuous Flush KRA
Mechanical Thrombolysis Catheter QEY
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
System, Ablation, Microwave And Accessories NEY
Catheter, Nephrostomy, General & Plastic Surgery GBO
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Powered Laser Surgical Instrument GEX
Aspiration Thrombectomy Catheter QEZ
Low Energy Direct Current Thermal Ablation System OAB
Accelerator, Linear, Medical IYE
System, Applicator, Radionuclide, Remote-Controlled JAQ
Dilator, Vessel, For Percutaneous Catheterization DRE
Catheter, Irrigation GBX
Introducer, Catheter DYB
Set, Administration, Intravascular FPA
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Catheter, Intravascular, Diagnostic DQO
Electrosurgical, Cutting & Coagulation & Accessories GEI
Needle, Hypodermic, Single Lumen FMI
Stents, Drains And Dilators For The Biliary Ducts FGE
Prostate Immobilizer Rectal Balloon PCT
Tubing, Pump, Cardiopulmonary Bypass DWE
Peripheral Mechanical Thrombectomy With Aspiration QEW
Wire, Guide, Catheter DQX
Trocar DRC
Cannula, Catheter DQR

Proprietary Names

Pulse Spray Infusion System UniFuse Infusion System Vortex MP Vascular Access Port Solero Microwave Tissues Ablation (MTA) Applicators (14cm, 19cm, 29cm) Solero Microwave Tissues Ablation (MTA) Generator Total Abscession Nephrostomy Drainage Catheter AngioVac Cannula D30 Plus Laser System EVLT Kit D15 Plus Laser System AlphaVac Multipurpose Mechanical Aspiration System F1885 NanoKnife LifePort Vascular Access Port Vortex LP Vascular Access Port Alatus Plus Vaginal Balloon Packing System Kit MINI STICK MAX COAXIAL MICROINTRODUCER KIT VenaCure NeverTouch Procedure Kits Uni-Fuse+ Infusion System Mini Stick ENVI Non-Vascular Introducer Kit VenaCure EVLT NeverTouch VenaCure EVLT Tre-Sheath LifePort Infusion Set VenaCure EVLT 400mm Perorator and Accessory Vein Ablation Kit AlphaVac Multipurpose Mechanical Aspiration (MMA) System F18 85 NanoKnife Single Electrode Probe NanoKnife Single Electrode Probe Spacer NanoKnife Single Electrode Activation Probe NanoKnife Procedure Activations Card NanoKnife Generator Canister VenaCure EVLT NeverTouch Direct Introducer Sheath Soft-Vu Angiographic Catheters Mariner Angiographic Catheters Habib Cable Habib 4X Habib 4X Laparoscopic Mariner Hydrophilic Angiographic Catheters AngiOptic Angiographic Catheters Accu-Vu Sizing Catheters 16 Gauge Entry Needle Solero MTA Cart LifeGuard Vision Safety Infusion Set LifeGuard Infusion Set Total Abscession General Drainage Catheters VenaCure EVLT NeverTouch Procedure Kit Xcela Plus Port with PASV Valve Technology BioFlo Port with ENDEXO Technology BioFlo Port with ENDEXO and PASV Valve Technology Xcela Plus Port EXODUS BELIEVE BILIARY DRAINAGE CATHETER EXODUS NUANCE NEPHROSTOMY DRAINAGE CATHETER EXODUS ARRAY MULTIPURPOSE DRAINAGE CATHETER IsoLoc AngioVac Soft-Vu, Mariner, AngiOPtic, Accu-Vu, Angiographic Catheters NanoKnife System AngioVac Circuit Pack VenaCure EVLT Nevertouch Procedure Kits VAXCEL MINI STICK KIT Vortex VX Vascular Access Port SmartPort+ SmartPort Plastic Smart Port CT IntelliFlow Pump Communication Cable MRI Extention Cable IntelliFlow Pump Software Module Generator Accessories (Foot Switch, Power Cords) RF Generator StarBurst Electrode AlphaVac Multipurpose Mechanical Aspiration (MMA) System NanoKnife 3 Generator AlphaVac MMA F1885 System Smart Port CT Low-Profile Smart Port CT Mini Vortex TR Vascular Access Port LifeValve Platinum Kit VenaCure EVLT NeverTouch-FRS SpeedLyser Infusion Catheter Kit Micro Access and Micro Introducers Triumph-1 Vascular Access Port BIOFLO PORT WITH ENDEXO AND PASV VALVE TECHNOLOGY BIOFLO PORT WITH ENDEXO TECHNOLOGY NMI Dual Port II Total Abscession Biliary Drainage Catheter

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility