Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000523114

FEI Number

1000523114

Entity Name

AngioDynamics, Inc.

City/State/Country

Marlborough, MA, US

Establishment Address

26 Forest St, Marlborough, MA 01752, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ANGIODYNAMICS, INC (Owner Number: 9028212)

Owner / Operator Contact Address

26 Forest St., --, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240397

PMA Number

N/A

All Registered 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 LifePort Vascular Access Port MINI STICK MAX COAXIAL MICROINTRODUCER KIT VenaCure NeverTouch Procedure Kits Uni-Fuse+ Infusion System LifePort Vascular Access Port LifePort Vascular Access Port 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 Uni-Fuse+ Infusion System VenaCure NeverTouch Procedure Kits 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 Soft-Vu 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 LifePort Vascular Access Port 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 Single Electrode Activation Probe NanoKnife 3 Generator NanoKnife Single Electrode Probe Spacer AngioVac Cannula AlphaVac MMA F1885 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2018-12-10
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2018-12-10
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2017-05-05
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2009-11-02
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2015-05-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2008-06-17
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2026-02-09
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-02-09
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2026-04-24
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2019-12-27
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2019-12-27
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2016-07-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2010-12-28
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-10-28
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2020-10-28
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2017-07-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-07-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-02-04
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2022-04-07
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2015-06-22
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2020-10-28
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-10-28
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2012-02-16
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2020-02-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-07-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2018-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2006-06-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2017-11-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-01-29
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-22
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2000-02-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-04-02
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2017-05-09
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2016-07-18
PCT	Prostate Immobilizer Rectal Balloon	Radiology	Class 2	892.5720	2019-12-27
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2019-08-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-04-13
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2024-12-16
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2015-05-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-07-31
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-07-31
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2016-07-18
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2020-05-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-07-21
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-07-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-18
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2021-06-08
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2019-06-26
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-12-01
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2024-04-10
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANGIODYNAMICS, INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015537049	ANGIODYNAMICS, INC	Queensbury, NY, US
1319211	ANGIODYNAMICS, INC.	Queensbury, NY, US
3017892510	ANGIODYNAMICS, INC	Glens Falls, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08
K912423	Med Institute, Inc.	VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112	1991-07-30
K961652	Arrow Intl., Inc.	LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017	1996-07-19
K893460	Therex Corp.	A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM	1989-06-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000523114. Last updated year: 2026. Please use registration number 1000523114 when referencing this establishment in official correspondence.