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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2018-12-10 |
| Mechanical Thrombolysis Catheter | QEY | Class 2 | Cardiovascular | No | 2018-12-10 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2008-01-22 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2017-05-05 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2009-11-02 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2015-05-18 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2008-06-17 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2026-02-09 |
| Low Energy Direct Current Thermal Ablation System | OAB | Class 2 | General, Plastic Surgery | No | 2026-04-24 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2019-12-27 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2019-12-27 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2016-07-18 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2017-07-21 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2017-07-21 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2008-01-21 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2020-02-27 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2018-11-30 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2006-06-15 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2010-01-29 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2016-07-18 |
| Prostate Immobilizer Rectal Balloon | PCT | Class 2 | Radiology | No | 2019-12-27 |
| Tubing, Pump, Cardiopulmonary Bypass | DWE | Class 2 | Cardiovascular | No | 2015-05-18 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2024-04-10 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2005-09-20 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2005-09-20 |
| Cannula, Catheter | DQR | Class 2 | Cardiovascular | No | 2005-09-20 |
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