FDA 510(k) Applications Submitted by ANGIODYNAMICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K242687 09/06/2024 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) Angiodynamics, Inc.
K202347 08/18/2020 UNIFUSE Infusion System with Cooper Wire AngioDynamics, Inc.
K192864 10/07/2019 UNI*FUSE Infusion System with Cooper Wire Angiodynamics, Inc.
K080451 02/19/2008 UNIBLATE ELECTROSURGICAL DEVICE ANGIODYNAMICS, INC.
K971314 04/09/1997 DCAT EMBOLECTOMY CATHETER SYSTEM ANGIODYNAMICS, INC.
K081472 05/27/2008 SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS ANGIODYNAMICS, INC.
K982346 07/06/1998 ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM ANGIODYNAMICS, INC.
K953825 08/15/1995 ANGIOFLUSH II FLUID MANAGEMENT SYSTEM ANGIODYNAMICS, INC.
K072375 08/23/2007 SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET ANGIODYNAMICS, INC.
K964034 10/08/1996 TRANSJUGULAR ACCESS SET ANGIODYNAMICS, INC.
K964033 10/08/1996 3F ANGIOPTIC ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC.
K110936 04/04/2011 DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC.
K101843 07/01/2010 DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC.
K181044 04/19/2018 400um Perforator and Accessory Vein Ablation Kit AngioDynamics, Inc.
K170775 03/14/2017 Mini Stick ENVI Non-Vascular Introducer Kit AngioDynamics, Inc.
K171921 06/27/2017 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc.
K963574 09/06/1996 PULSE*SPRAY INJECTOR ANGIODYNAMICS, INC.
K093406 11/02/2009 MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 ANGIODYNAMICS, INC.
K240397 02/09/2024 AlphaVac MMA F1885 System (H787253020) AngioDynamics, Inc.
K190594 03/07/2019 AngioVac C20, AngioVac C180 AngioDynamics, Inc.
K182250 08/20/2018 Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) AngioDynamics, Inc.
K211081 04/12/2021 AlphaVac Multipurpose Mechanical Aspiration (MMA) System AngioDynamics, Inc.
K221883 06/29/2022 Solero Microwave Tissue Ablation (MTA) System and Accessories AngioDynamics, Inc.
K213067 09/23/2021 Solero Microwave Tissue Ablation (MTA) System and Accessories AngioDynamics, Inc.
K223581 12/01/2022 Solero Microwave Tissue Ablation (MTA) System and Accessories AngioDynamics, Inc.
K212386 08/02/2021 AngioVac F18 85 AngioDynamics, Inc.
K213388 10/14/2021 AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System AngioDynamics, Inc.
K102329 08/17/2010 NANOKNIFE SYSTEM ANGIODYNAMICS, INC.
K231945 06/30/2023 VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits AngioDynamics, Inc.
K133561 11/20/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH ANGIODYNAMICS, INC.
K142889 10/03/2014 Celerity PICC Tip Confirmation System ANGIODYNAMICS, INC.
K170695 03/07/2017 VenaCure EVLT NeverTouch Direct Introducer Sheath AngioDynamics, Inc.
K162914 10/17/2016 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc.
K163356 11/30/2016 Pulse* Spray Infusion System, Uni*Fuse Infusion System ANGIODYNAMICS, INC.
K101017 04/12/2010 ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS ANGIODYNAMICS, INC.
K150089 01/16/2015 NanoKnife System ANGIODYNAMICS, INC.
K060023 01/04/2006 ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER ANGIODYNAMICS, INC.
K100199 01/22/2010 ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT ANGIODYNAMICS, INC.
K110225 01/25/2011 ANGIODYNAMICS, INC. VENACURE 1470 LASER ANGIODYNAMICS, INC.
K170258 01/27/2017 SpeedLyser Infusion Catheter Kit AngioDynamics, Inc.
K080287 02/04/2008 ONCOBIONIC BIPOLAR ELECTRODE ANGIODYNAMICS, INC.
K030415 02/07/2003 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K070378 02/08/2007 ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC.
K080400 02/13/2008 ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC.
K040402 02/17/2004 ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC.
K040446 02/20/2004 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K070613 03/05/2007 ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K070615 03/05/2007 ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K170743 03/10/2017 AngioDynamics Total Abscession Biliary Drainage Catheter AngioDynamics, Inc.
K130671 03/12/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT ANGIODYNAMICS, INC.
K040728 03/22/2004 ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT ANGIODYNAMICS, INC.
K060887 03/31/2006 ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K031233 04/17/2003 ANDIODYNAMICS, INC. ELVS PROCEDURE KIT ANGIODYNAMICS, INC.
K051060 04/26/2005 ANGIODYNAMICS PROFILER PTA BALLOON CATHETER ANGIODYNAMICS, INC.
K061178 04/27/2006 ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT ANGIODYNAMICS, INC.
K991540 05/03/1999 WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ANGIODYNAMICS, INC.
K051142 05/04/2005 ANGIODYNAMICS TUMESCENT INFUSION DEVICE ANGIODYNAMICS, INC.
K001578 05/22/2000 ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC.
K991793 05/26/1999 ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM ANGIODYNAMICS, INC.
K031626 05/27/2003 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K041420 05/28/2004 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K161596 06/09/2016 Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters AngioDynamics, Inc.
K002101 06/12/2000 ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER ANGIODYNAMICS, INC.
K061733 06/20/2006 ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC.
K051655 06/21/2005 ANGIODYNAMICS, INC., MICRO ACCESS KITS ANGIODYNAMICS, INC.
K151724 06/26/2015 AngioDynamics Mariner Angiographic Catheters ANGIODYNAMICS, INC.
K032069 07/03/2003 WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ANGIODYNAMICS, INC.
K071959 07/16/2007 ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC.
K032376 08/01/2003 ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC.
K072196 08/07/2007 ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC.
K112452 08/25/2011 ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS ANGIODYNAMICS, INC.
K062609 09/05/2006 MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER ANGIODYNAMICS, INC.
K112600 09/07/2011 ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT ANGIODYNAMICS, INC.
K142614 09/16/2014 AngioDynamics VenaCure EVLT TreÆ Sheath and VenaCure EVLT NeverTouch Procedure Kits AngioDynamics, Inc.
K102796 09/27/2010 ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT ANGIODYNAMICS, INC.
K033443 10/29/2003 SPEEDLYSER INFUSION CATHETER KIT ANGIODYNAMICS, INC.
K163141 11/09/2016 NAMIC ClearaCIL Contrast Injection Lines AngioDynamics, Inc.
K073464 12/10/2007 ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC.
K173762 12/11/2017 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters AngioDynamics, Inc.
K003901 12/18/2000 ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC.
K190559 03/05/2019 SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports AngioDynamics, Inc.
K142593 09/15/2014 AngioVac Cannula AngioDynamics, Inc.


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