Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319211

FEI Number

1319211

Entity Name

ANGIODYNAMICS, INC.

City/State/Country

Queensbury, NY, US

Establishment Address

603 QUEENSBURY AVE., Queensbury, NY 12804, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

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

K213388

PMA Number

N/A

All Registered 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 LifePort Vascular Access Port AngioVac 16 Gauge Entry Needle AlphaVac Multipurpose Mechanical Aspiration System F1885 VenaCure EVLT 400mm Perorator and Accessory Vein Ablation Kit LifePort Vascular Access Port 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 AngioVac SmartPort+ SmartPort Plastic D30 Plus Laser System EVLT Kit D15 Plus Laser System LifePort Vascular Access Port 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 LifePort Vascular Access Port Total Abscession Nephrostomy Drainage Catheter LifePort Vascular Access Port VenaCure EVLT Nevertouch Procedure Kits Pulse Spray Infusion System UniFuse Infusion System Triumph-1 Vascular Access Port Canister VenaCure NeverTouch Procedure Kits LifePort Vascular Access Port AngioVac Cannula Vortex MP Vascular Access Port BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY 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 LifePort Vascular Access Port AlphaVac Multipurpose Mechanical Aspiration (MMA) System F18 85

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-10-28
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2020-10-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-22
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2017-05-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2005-09-20
DRC	Trocar	Cardiovascular	Class 2	870.1390	2005-09-20
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2005-09-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2005-09-20
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2017-04-11
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2021-06-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2010-12-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-04-13
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2000-02-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-05-09
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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-05-09
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
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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-01-29
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2026-02-09
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-02-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-02-04
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-07-18
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2017-07-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-07-21
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2020-03-02
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2018-11-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2021-11-08
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2020-05-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2008-06-17
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-06-06
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
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2018-12-10
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2018-12-10
OAB	Low Energy Direct Current Thermal Ablation System	General, Plastic Surgery	Class 2	878.4400	2026-04-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-12-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2016-07-18
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-09-07
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2009-11-02
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
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
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
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2020-02-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2012-02-16
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	2025-12-01
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-07-18
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-07-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-21
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2022-04-07

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
1000523114	AngioDynamics, Inc.	Marlborough, MA, US
3017892510	ANGIODYNAMICS, INC	Glens Falls, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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1000523114	AngioDynamics, Inc.	Marlborough, MA, US
3013750125	Medical Components, Inc.	Yuma, AZ, US
9617592	BARD REYNOSA S.A. DE C.V.	REYNOSA Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319211. Last updated year: 2026. Please use registration number 1319211 when referencing this establishment in official correspondence.