Data / Medical devices / United States / AngioDynamics, Inc.
AngioDynamics, Inc.: FDA-registered device maker in Marlborough, MA, United States, 68 510(k) clearances
AngioDynamics, Inc. is registered with the FDA (registration 1000523114) in Marlborough, MA, United States. It lists 26 device types. The FDA files 68 510(k) clearances under its listings, the newest dated March 24, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000523114
- Address
- 26 Forest St, Marlborough, MA, United States, 01752
- Owner or operator
- ANGIODYNAMICS, INC (9028212)
- Roles
- Specification developer
- First device listed
- February 8, 2000
- Registered through
- 2026
- Brand names listed
- 16 Gauge Entry Needle, Accu-Vu Sizing Catheters, Alatus Plus Vaginal Balloon Packing System Kit, AlphaVac MMA F1885 System, AlphaVac Multipurpose Mechanical Aspiration (MMA) System, AlphaVac Multipurpose Mechanical Aspiration (MMA) System F18 85, AlphaVac Multipurpose Mechanical Aspiration System F1885, AngiOptic Angiographic Catheters and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2026 | K253198 | NanoKnife Generator (H78720300351US0) | OAB | Substantially Equivalent | Angiodynamics | accessdata.fda.gov |
| November 24, 2025 | K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| October 24, 2025 | K253106 | AngioVac Cannula | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 6, 2024 | K242687 | 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) | OAB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| April 1, 2024 | K240397 | AlphaVac MMA F1885 System (H787253020) | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 20, 2023 | K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 27, 2023 | K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 7, 2023 | K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| April 4, 2022 | K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 3, 2021 | K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| September 30, 2021 | K212386 | AngioVac F18 85 | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 4, 2021 | K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | QEZ | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| September 15, 2020 | K202347 | UNIFUSE Infusion System with Cooper Wire | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 1, 2020 | K192864 | UNI*FUSE Infusion System with Cooper Wire | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 22, 2020 | K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | LJT | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 5, 2019 | K190594 | AngioVac C20, AngioVac C180 | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 18, 2019 | K183385 | NanoKnife System | OAB | Substantially Equivalent | Angiodynamics | accessdata.fda.gov |
| February 28, 2019 | K182250 | Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 18, 2018 | K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters | DQO | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 5, 2018 | K181044 | 400um Perforator and Accessory Vein Ablation Kit | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| August 24, 2017 | K171921 | VenaCure EVLT NeverTouch Procedure Kit | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| July 19, 2017 | K170775 | Mini Stick ENVI Non-Vascular Introducer Kit | DYB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 30, 2017 | K170695 | VenaCure EVLT NeverTouch Direct Introducer Sheath | DYB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 30, 2017 | K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 5, 2017 | K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| April 28, 2017 | K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | DQO | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 30, 2017 | K170743 | AngioDynamics Total Abscession Biliary Drainage Catheter | FGE | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| February 21, 2017 | K170258 | SpeedLyser Infusion Catheter Kit | QEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| November 16, 2016 | K162914 | VenaCure EVLT NeverTouch Procedure Kit | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 6, 2016 | K151239 | NMI DUAL PORT II | LJT | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| December 4, 2015 | K153228 | NMI Port, NMI Port II | LJT | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| September 24, 2015 | K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter | FGE | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| June 18, 2015 | K150089 | NanoKnife System | OAB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 11, 2014 | K142607 | AngioVac Circuit | DWE | Substantially Equivalent | Angiodynamics | accessdata.fda.gov |
| November 12, 2014 | K142593 | AngioVac Cannula | DWF | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| October 10, 2014 | K142614 | AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure Kits | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| January 28, 2014 | DEN130036 | PROSTATE IMMOBILIZER RECTAL BALLOON | PCT | Unknown | Radiadyne | accessdata.fda.gov |
| September 27, 2013 | K132713 | NMI COAXIAL MICROINTRODUCER SET | DRE | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| August 8, 2013 | K131694 | NMI PORT II CATHETER | LJT | Substantially Equivalent | Navilyst Medical, Inc. | accessdata.fda.gov |
| March 26, 2013 | K130671 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 30, 2012 | K112452 | ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS | DQO | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| January 30, 2012 | K112600 | ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 15, 2010 | K102796 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT | GEX | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 17, 2010 | K101017 | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS | LJT | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 7, 2009 | K092534 | ALATUS VAGINAL BALLOON PACKING SYSTEM | JAQ | Substantially Equivalent | Radiadyne | accessdata.fda.gov |
| February 1, 2007 | K062414 | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET | LJT | Substantially Equivalent | Rita Medical Systems, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062935 | HABIB 4X LAPAROSCOPIC | GEI | Substantially Equivalent | Rita Medical Systems | accessdata.fda.gov |
| September 12, 2005 | K051655 | ANGIODYNAMICS, INC., MICRO ACCESS KITS | DQR | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| August 15, 2005 | K051420 | HABIB 4X | GEI | Substantially Equivalent | Emcision , Ltd. | accessdata.fda.gov |
| December 1, 2004 | K041957 | EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS | GEX | Substantially Equivalent | Diomed, Inc. | accessdata.fda.gov |
| April 28, 2004 | K040989 | RITA SYSTEMS | GEI | Substantially Equivalent | Rita Medical Systems | accessdata.fda.gov |
| November 18, 2003 | K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| September 9, 2003 | K032557 | TRIUMPH VTX WITH LIFEVALVE CATHETER | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| March 29, 2002 | K013871 | LIFEGUARD SAFETY INFUSION SET | FPA | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| April 10, 2001 | K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| February 12, 2001 | K010189 | VORTEX ACCESS SYSTEM | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| March 13, 1998 | K974640 | COAXIAL DILATOR SET | DRE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 2, 1996 | K961088 | NON-CORING NEEDLE | FMI | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 26, 1996 | K953529 | STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM | LJT | Substantially Equivalent | Strato/Infusaid, Inc. | accessdata.fda.gov |
| August 29, 1995 | K951814 | TRIUMPH-1 PORT | LJT | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| July 7, 1993 | K915273 | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| September 23, 1992 | K921674 | LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE | FPA | Substantially Equivalent | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905852 | STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905850 | STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905849 | STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905845 | STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 19, 1991 | K905839 | STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED | LJT | Unknown | Strato Medical Corp. | accessdata.fda.gov |
| April 15, 1991 | K911355 | LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 | LJT | Substantially Equivalent | Strato Medical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 25, 2013 | 67122 | Class II | Terminated | Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F | Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier. | accessdata.fda.gov |
| September 21, 2005 | 33623 | Not yet classified | Terminated | Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826 | Devices for which sterility may be compromised as evidenced by a loss of package integrity. | accessdata.fda.gov |
| June 16, 2004 | 29383 | Not yet classified | Terminated | Dispersive Electrodes packaged in an 8x10 plastic container. | Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed. | accessdata.fda.gov |
| October 6, 2003 | 27500 | Not yet classified | Terminated | RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649 | The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading. | accessdata.fda.gov |
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Updated March 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.