| VERAFEYE Imaging Catheter (VF-VIC-002) (K261849) | Luma Vision Limited | 2026-07-24 |
| Novasight Hybrid System (K252945) | Conavi Medical, Inc. | 2026-04-17 |
| OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) (K260816) | Boston Scientific | 2026-04-08 |
| Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (K253399) | Volcano Corporation (Dba Philips Image Guided Therapy Device | 2025-10-28 |
| XC11 ICE System, USA (K250955) | Yorlabs, Inc. | 2025-10-22 |
| TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (K250913) | Jiangsu Tingsn Technology Co., Ltd. | 2025-07-19 |
| ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (K251211) | ABBOTT MEDICAL | 2025-05-23 |
| ViewFlex™ X ICE Catheter, Sensor Enabled™ (K251231) | ABBOTT MEDICAL | 2025-05-20 |
| VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103) | Philips Image Guided Therapy Corporation | 2025-05-09 |
| VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (K242893) | Luma Vision Limited | 2025-03-24 |
| NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (K241540) | Biosense Webster, Inc. | 2024-06-28 |
| SOUNDSTAR™ CRYSTAL Ultrasound Catheter (K240050) | Biosense Webster, Inc. | 2024-06-12 |
| Provisio™ SLT IVUS™ System (K233948) | Provisio Medical, Inc. | 2024-04-23 |
| AcuNav Crystal Ultrasound Catheter (K233270) | Siemens Medical Solutions USA, Inc. | 2023-10-28 |
| OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter (K230453) | Boston Scientific Corporation | 2023-05-18 |
| NUVISION™ NAV Ultrasound Catheter (K223766) | Biosense Webster, Inc. | 2023-02-16 |
| ViewFlex Xtra ICE Catheter (K223077) | Irvine Biomedical, A St. Jude Medical Company | 2022-12-07 |
| OptiCross™ 18 Peripheral Imaging Catheter (K222568) | Boston Scientific Corporation | 2022-09-23 |
| OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD (K213593) | Boston Scientific Corporation | 2022-01-14 |
| ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter (K212959) | Siemens Medical Solutions USA, Inc. | 2021-10-15 |
| NuVision ICE Catheter (K201775) | Nuvera Medical, Inc. | 2021-03-05 |
| ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter (K203726) | Siemens Medical Solutions USA, Inc. | 2021-01-19 |
| VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter (K200812) | Philips Image Guided Therapy Corporation | 2020-09-02 |
| NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (K200195) | Northeast Scientific, Inc. | 2020-06-22 |
| Reconnaissance PV .018 OTW Digital IVUS Catheter (K200410) | Philips Image Guided Therapy Corporation | 2020-05-22 |
| ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (K193183) | Acist Medical Systems, Inc. | 2020-03-20 |
| ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K191175) | Acist Medical Systems, Inc. | 2019-06-27 |
| Novasight Hybrid System (K172258) | Conavi Medical, Inc. | 2018-04-27 |
| OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173820) | Boston Scientific Corporation | 2018-01-17 |
| ACUSON AcuNav Volume Intracardiac Echocardiography Catheter (K173618) | Siemens Medical Solutions USA, Inc. | 2017-12-19 |
| OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173284) | Boston Scientific Corporation | 2017-11-16 |
| ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K173063) | Acist Medical Systems, Inc. | 2017-10-23 |
| AcuNav V 10F Ultrasound Catheter (K170992) | Siemens Medical Solutions USA, Inc. | 2017-06-15 |
| AcuNav Diagnostic Ultrasound Catheter 8F,10F (K170263) | Siemens Medical Solutions USA, Inc. | 2017-06-15 |
| AcuNav Volume ICE Catheter (K163478) | Siemens Medical Solutions USA, Inc. | 2017-02-09 |
| REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (K160583) | Volcano Corporation | 2016-10-26 |
| OptiCross 18, 30 MHz Peripheral Imaging Catheter (K160514) | Boston Scientific Corporation | 2016-06-22 |
| OptiCross X, 40 MHz Coronary Imaging Catheter (K161125) | Boston Scientific Corporation | 2016-05-19 |
| OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) (K153617) | Boston Scientific Corporation | 2016-02-25 |
| Visions PV .035 Digital IVUS Catheter (K153094) | Volcano Corporation | 2015-12-31 |
| Visions PV.014P RX Digital IVUS Catheter (K152829) | Volcano Corporation | 2015-11-19 |
| Volcano Visions PV .018 Digital IVUS Catheter (K150442) | Volcano Corporation | 2015-09-04 |
| EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM (K143701) | Volcano Corporation | 2015-08-26 |
| ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS (K141618) | Arrow International, Inc (Subsidiary of Teleflex I | 2014-07-08 |
| VIEWFLEX XTRA ICE CATHETER (K133853) | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014-05-19 |
| SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER (K140318) | Biosense Webster | 2014-03-12 |
| CG+ ARROW JACC POWERED BY ARROW VPS STYLET (K132133) | Arrow International (Subsidiary of Teleflex Inc.) | 2013-09-26 |
| OPTICROSS 40 MHZ CORONARY IMAGING CATHETER (K123621) | Boston Scientific Corp | 2013-04-15 |
| VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE (K123813) | Vasonova, Inc. | 2013-01-18 |
| HD-IVUS ULTRASOUND IMAGING SYSTEM (K122878) | Silicon Vally Medical Instruments, Inc. | 2013-01-11 |
| VISIONS PV .035 DITITAL IVUS CATHETER (K121273) | Volcano Corporation | 2012-09-10 |
| KODAMA INTRAVASCULAR ULRASOUND CATHETER (K113008) | Silicon Vally Medical Instruments, Inc. | 2012-06-14 |
| EAGLE EYE PLATINUM ST CATHETER (K120697) | Volcano Corporation | 2012-04-05 |
| SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER (K112050) | Biosense Webster, Inc. | 2011-11-18 |
| ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER (K111043) | Boston Scientific Corp | 2011-08-04 |
| VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE (K103260) | Vasonova, Inc. | 2011-02-18 |
| VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET (K103255) | Vasonova, Inc. | 2011-02-18 |
| SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 (K101138) | Biosense Webster, Inc. | 2010-06-22 |
| EAGLE EYE PLATINUM DIGITAL IVUS CATHETER (K092596) | Volcano Corporation | 2009-12-10 |
| SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 (K091352) | Biosense Webster, Inc. | 2009-12-04 |
| SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 (K092064) | Biosense Webster, Inc. | 2009-08-07 |
| FLOWPICC CONSOLE (K081626) | Vasonova, Inc. | 2008-10-15 |
| ACUNAV V ULTRASOUND CATHETER (K081808) | Siemens Medical Solutions USA, Inc. | 2008-09-26 |
| FLOWPICC STYLET (K081625) | Vasonova, Inc. | 2008-09-26 |
| REVOLUTION 45MHZ IVUS IMAGING CATHETER (K080891) | Volcano Corporation | 2008-05-12 |
| EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 (K073473) | Volcano Corporation | 2008-01-14 |
| VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K071554) | Volcano Corporation | 2008-01-04 |
| VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 (K071660) | Volcano Corporation | 2007-08-31 |
| ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F (K071234) | Siemens Medical Solutions USA, Inc. | 2007-06-29 |
| SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 (K070242) | Biosense Webster, Inc. | 2007-05-15 |
| EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 (K051337) | Volcano Corporation | 2005-08-18 |
| ILAB ULTRASOUND IMAGING SYSTEM (K051679) | Boston Scientific Corp | 2005-07-14 |
| REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER (K050995) | Volcano Corporation | 2005-06-20 |
| ACUSON ACUNAV 8F ULTRASOUND CATHETER (K042593) | Siemens Medical Solutions USA, Inc. | 2004-10-15 |
| MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 (K041727) | Boston Scientific Scimed, Inc. | 2004-07-23 |
| COMBOMAP PRESSURE AND FLOW SYSTEM (K041134) | Volcano Therapeutics, Inc. | 2004-06-02 |
| ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER (K033650) | Siemens Medical Solutions USA, Inc. | 2004-02-24 |
| JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 (K031346) | Jomed, Inc. | 2003-06-23 |
| CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN (K030524) | Cd Leycom BV | 2003-03-03 |