Medical Device Manufacturer · US , Glens Falls , NY

AngioDynamics, Inc.

87 submissions · 82 cleared · Since 1995
87
Total
82
Cleared
0
Denied

AngioDynamics, Inc. — FDA 510(k) Submissions

AngioDynamics, Inc. has submitted 87 FDA 510(k) premarket notifications since 1995, of which 82 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Catheter, Intravascular, Diagnostic, Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Mechanical Thrombolysis Catheter, Stents, Drains And Dilators For The Biliary Ducts . Use the specialty filter in the sidebar to narrow results.

87 devices
1–25 of 87
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · QEZ Aspiration Thrombectomy... · Cardiovascular
Nov 2025 108d
AngioVac Cannula
K253106 · DWF Catheter, Cannula And... · Cardiovascular
Oct 2025 30d
NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
K242687 · OAB Low Energy Direct Current... · Gastroenterology & Urology
Dec 2024 91d
AlphaVac MMA F1885 System (H787253020)
K240397 · QEZ Aspiration Thrombectomy... · Cardiovascular
Apr 2024 52d
VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
K231945 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2023 20d
Solero Microwave Tissue Ablation (MTA) System and Accessories
K223581 · NEY System, Ablation,... · General & Plastic Surgery
Mar 2023 116d
Solero Microwave Tissue Ablation (MTA) System and Accessories
K221883 · NEY System, Ablation,... · General & Plastic Surgery
Mar 2023 251d
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
K213388 · QEZ Aspiration Thrombectomy... · Cardiovascular
Apr 2022 172d
Solero Microwave Tissue Ablation (MTA) System and Accessories
K213067 · NEY System, Ablation,... · General & Plastic Surgery
Dec 2021 71d
AngioVac F18 85
K212386 · DWF Catheter, Cannula And... · Cardiovascular
Sep 2021 59d
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · QEZ Aspiration Thrombectomy... · Cardiovascular
Jun 2021 53d
UNIFUSE Infusion System with Cooper Wire
K202347 · QEY Mechanical Thrombolysis... · Cardiovascular
Sep 2020 28d
UNI*FUSE Infusion System with Cooper Wire
K192864 · QEY Mechanical Thrombolysis... · Cardiovascular
Jun 2020 238d
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · LJT Port & Catheter,... · General Hospital
May 2020 444d
AngioVac C20, AngioVac C180
K190594 · DWF Catheter, Cannula And... · Cardiovascular
Jul 2019 120d
Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
K182250 · NEY System, Ablation,... · General & Plastic Surgery
Feb 2019 192d
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
K173762 · DQO Catheter, Intravascular,... · Cardiovascular
Jul 2018 219d
400um Perforator and Accessory Vein Ablation Kit
K181044 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2018 77d
VenaCure EVLT NeverTouch Procedure Kit
K171921 · GEX Powered Laser Surgical... · General & Plastic Surgery
Aug 2017 58d
Mini Stick ENVI Non-Vascular Introducer Kit
K170775 · DYB Introducer, Catheter · Cardiovascular
Jul 2017 127d
Pulse* Spray Infusion System, Uni*Fuse Infusion System
K163356 · QEY Mechanical Thrombolysis... · Cardiovascular
May 2017 181d
VenaCure EVLT NeverTouch Direct Introducer Sheath
K170695 · DYB Introducer, Catheter · Cardiovascular
May 2017 84d
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
K162449 · NEY System, Ablation,... · General & Plastic Surgery
May 2017 246d
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
K161596 · DQO Catheter, Intravascular,... · Cardiovascular
Apr 2017 323d
AngioDynamics Total Abscession Biliary Drainage Catheter
K170743 · FGE Stents, Drains And... · Gastroenterology & Urology
Mar 2017 20d

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