FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K193183 |
ACIST Medical Systems, Inc. |
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter |
03/20/2020 |
K191175 |
ACIST Medical Systems, Inc. |
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
06/27/2019 |
K173063 |
ACIST Medical Systems, Inc. |
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System |
10/23/2017 |
K141618 |
ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I |
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS |
07/08/2014 |
K132133 |
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
CG+ ARROW JACC POWERED BY ARROW VPS STYLET |
09/26/2013 |
K140318 |
BIOSENSE WEBSTER |
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER |
03/12/2014 |
K223766 |
Biosense Webster, Inc. |
NUVISIONÖ NAV Ultrasound Catheter |
02/16/2023 |
K091352 |
BIOSENSE WEBSTER, INC. |
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 |
12/04/2009 |
K101138 |
BIOSENSE WEBSTER, INC. |
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 |
06/22/2010 |
K070242 |
BIOSENSE WEBSTER, INC. |
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 |
05/15/2007 |
K092064 |
BIOSENSE WEBSTER, INC. |
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 |
08/07/2009 |
K112050 |
BIOSENSE WEBSTER, INC. |
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER |
11/18/2011 |
K111043 |
BOSTON SCIENTIFIC CORP. |
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER |
08/04/2011 |
K051679 |
BOSTON SCIENTIFIC CORP. |
ILAB ULTRASOUND IMAGING SYSTEM |
07/14/2005 |
K123621 |
BOSTON SCIENTIFIC CORP. |
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER |
04/15/2013 |
K160514 |
BOSTON SCIENTIFIC CORPORATION |
OptiCross 18, 30 MHz Peripheral Imaging Catheter |
06/22/2016 |
K173820 |
Boston Scientific Corporation |
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) |
01/17/2018 |
K153617 |
BOSTON SCIENTIFIC CORPORATION |
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) |
02/25/2016 |
K173284 |
Boston Scientific Corporation |
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) |
11/16/2017 |
K161125 |
Boston Scientific Corporation |
OptiCross X, 40 MHz Coronary Imaging Catheter |
05/19/2016 |
K213593 |
Boston Scientific Corporation |
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD |
01/14/2022 |
K222568 |
Boston Scientific Corporation |
OptiCrossÖ 18 Peripheral Imaging Catheter |
09/23/2022 |
K230453 |
Boston Scientific Corporation |
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter |
05/18/2023 |
K041727 |
BOSTON SCIENTIFIC SCIMED, INC. |
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 |
07/23/2004 |
K030524 |
CD LEYCOM BV |
CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN |
03/03/2003 |
K172258 |
Conavi Medical Inc. |
Novasight Hybrid System |
04/27/2018 |
K223077 |
Irvine Biomedical, a St. Jude Medical Company |
ViewFlex Xtra ICE Catheter |
12/07/2022 |
K133853 |
IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY |
VIEWFLEX XTRA ICE CATHETER |
05/19/2014 |
K031346 |
JOMED, INC. |
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 |
06/23/2003 |
K200195 |
Northeast Scientific, Inc. |
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter |
06/22/2020 |
K201775 |
NuVera Medical, Inc. |
NuVision ICE Catheter |
03/05/2021 |
K200410 |
Philips Image Guided Therapy Corporation |
Reconnaissance PV .018 OTW Digital IVUS Catheter |
05/22/2020 |
K200812 |
Philips Image Guided Therapy Corporation |
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter |
09/02/2020 |
K081808 |
SIEMENS MEDICAL SOLUTIONS USA INC. |
ACUNAV V ULTRASOUND CATHETER |
09/26/2008 |
K170992 |
Siemens Medical Solutions USA, Inc |
AcuNav V 10F Ultrasound Catheter |
06/15/2017 |
K033650 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER |
02/24/2004 |
K071234 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F |
06/29/2007 |
K170263 |
Siemens Medical Solutions USA, Inc. |
AcuNav Diagnostic Ultrasound Catheter 8F,10F |
06/15/2017 |
K163478 |
Siemens Medical Solutions USA, Inc. |
AcuNav Volume ICE Catheter |
02/09/2017 |
K042593 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ACUSON ACUNAV 8F ULTRASOUND CATHETER |
10/15/2004 |
K173618 |
Siemens Medical Solutions USA, Inc. |
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter |
12/19/2017 |
K203726 |
Siemens Medical Solutions USA, Inc. |
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter |
01/19/2021 |
K212959 |
Siemens Medical Solutions USA, Inc. |
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter |
10/15/2021 |
K122878 |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
HD-IVUS ULTRASOUND IMAGING SYSTEM |
01/11/2013 |
K113008 |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
KODAMA INTRAVASCULAR ULRASOUND CATHETER |
06/14/2012 |
K081626 |
VASONOVA INC. |
FLOWPICC CONSOLE |
10/15/2008 |
K081625 |
VASONOVA INC. |
FLOWPICC STYLET |
09/26/2008 |
K103260 |
VASONOVA INC. |
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE |
02/18/2011 |
K123813 |
VASONOVA INC. |
VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE |
01/18/2013 |
K103255 |
VASONOVA INC. |
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET |
02/18/2011 |
K073473 |
VOLCANO CORPORATION |
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 |
01/14/2008 |
K051337 |
VOLCANO CORPORATION |
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 |
08/18/2005 |
K143701 |
VOLCANO CORPORATION |
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM |
08/26/2015 |
K092596 |
VOLCANO CORPORATION |
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER |
12/10/2009 |
K120697 |
VOLCANO CORPORATION |
EAGLE EYE PLATINUM ST CATHETER |
04/05/2012 |
K160583 |
VOLCANO CORPORATION |
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip |
10/26/2016 |
K050995 |
VOLCANO CORPORATION |
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER |
06/20/2005 |
K080891 |
VOLCANO CORPORATION |
REVOLUTION 45MHZ IVUS IMAGING CATHETER |
05/12/2008 |
K153094 |
Volcano Corporation |
Visions PV .035 Digital IVUS Catheter |
12/31/2015 |
K121273 |
VOLCANO CORPORATION |
VISIONS PV .035 DITITAL IVUS CATHETER |
09/10/2012 |
K071660 |
VOLCANO CORPORATION |
VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 |
08/31/2007 |
K152829 |
Volcano Corporation |
Visions PV.014P RX Digital IVUS Catheter |
11/19/2015 |
K071554 |
VOLCANO CORPORATION |
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM |
01/04/2008 |
K150442 |
Volcano Corporation |
Volcano Visions PV .018 Digital IVUS Catheter |
09/04/2015 |
K041134 |
VOLCANO THERAPEUTICS, INC. |
COMBOMAP PRESSURE AND FLOW SYSTEM |
06/02/2004 |