Catheter, Ultrasound, Intravascular

K number K261696

OBJ 2026-07-24

VERAFEYE Imaging Catheter (VF-VIC-002)

Applicant Luma Vision Limited

K number K261849

OBJ 2026-04-17

Novasight Hybrid System

Applicant Conavi Medical, Inc.

K number K252945

OBJ 2026-04-08

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)

Applicant Boston Scientific

K number K260816

OBJ 2025-10-28

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

Applicant Volcano Corporation (Dba Philips Image Guided Therapy Device

K number K253399

OBJ 2025-10-22

XC11 ICE System, USA

Applicant Yorlabs, Inc.

K number K250955

OBJ 2025-07-19

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

Applicant Jiangsu Tingsn Technology Co., Ltd.

K number K250913

OBJ 2025-05-23

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™

Applicant ABBOTT MEDICAL

K number K251211

OBJ 2025-05-20

ViewFlex™ X ICE Catheter, Sensor Enabled™

Applicant ABBOTT MEDICAL

K number K251231

OBJ 2025-05-09

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)

Applicant Philips Image Guided Therapy Corporation

K number K251103

OBJ 2025-03-24

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

Applicant Luma Vision Limited

K number K242893

OBJ 2024-06-28

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter

Applicant Biosense Webster, Inc.

K number K241540

OBJ 2024-06-12

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

Applicant Biosense Webster, Inc.

K number K240050

OBJ 2024-04-23

Provisio™ SLT IVUS™ System

Applicant Provisio Medical, Inc.

K number K233948

OBJ 2023-10-28

AcuNav Crystal Ultrasound Catheter

K number K233270

OBJ 2023-05-18

OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter

K number K230453

OBJ 2023-02-16

NUVISION™ NAV Ultrasound Catheter

Applicant Biosense Webster, Inc.

K number K223766

OBJ 2022-12-07

ViewFlex Xtra ICE Catheter

Applicant Irvine Biomedical, A St. Jude Medical Company

K number K223077

OBJ 2022-09-23

OptiCross™ 18 Peripheral Imaging Catheter

K number K222568

OBJ 2022-01-14

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

K number K213593

OBJ 2021-10-15

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

K number K212959

OBJ 2021-03-05

NuVision ICE Catheter

Applicant Nuvera Medical, Inc.

K number K201775

OBJ 2021-01-19

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

K number K203726

OBJ 2020-09-02

VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

Applicant Philips Image Guided Therapy Corporation

K number K200812

OBJ 2020-06-22

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

Applicant Northeast Scientific, Inc.

K number K200195

OBJ 2020-05-22

Reconnaissance PV .018 OTW Digital IVUS Catheter

Applicant Philips Image Guided Therapy Corporation

K number K200410

OBJ 2020-03-20

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

Applicant Acist Medical Systems, Inc.

K number K193183

OBJ 2019-06-27

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Applicant Acist Medical Systems, Inc.

K number K191175

OBJ 2018-04-27

Novasight Hybrid System

Applicant Conavi Medical, Inc.

K number K172258

OBJ 2018-01-17

OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)

K number K173820

OBJ 2017-12-19

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

K number K173618

OBJ 2017-11-16

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)

K number K173284

OBJ 2017-10-23

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Applicant Acist Medical Systems, Inc.

K number K173063

OBJ 2017-06-15

AcuNav V 10F Ultrasound Catheter

K number K170992

OBJ 2017-06-15

AcuNav Diagnostic Ultrasound Catheter 8F,10F

K number K170263

OBJ 2017-02-09

AcuNav Volume ICE Catheter

K number K163478

OBJ 2016-10-26

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

Applicant Volcano Corporation

K number K160583

OBJ 2016-06-22

OptiCross 18, 30 MHz Peripheral Imaging Catheter

K number K160514

OBJ 2016-05-19

OptiCross X, 40 MHz Coronary Imaging Catheter

K number K161125

OBJ 2016-02-25

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)

K number K153617

OBJ 2013-09-26

CG+ ARROW JACC POWERED BY ARROW VPS STYLET

Applicant Arrow International (Subsidiary of Teleflex Inc.)

K number K132133

OBJ 2013-04-15

OPTICROSS 40 MHZ CORONARY IMAGING CATHETER

Applicant Boston Scientific Corp

K number K123621

OBJ 2013-01-18

VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE

Applicant Vasonova, Inc.

K number K123813

OBJ 2013-01-11

HD-IVUS ULTRASOUND IMAGING SYSTEM

Applicant Silicon Vally Medical Instruments, Inc.

K number K122878

OBJ 2012-09-10

VISIONS PV .035 DITITAL IVUS CATHETER

Applicant Volcano Corporation

K number K121273

OBJ 2012-06-14

KODAMA INTRAVASCULAR ULRASOUND CATHETER

Applicant Silicon Vally Medical Instruments, Inc.

K number K113008

OBJ 2012-04-05

EAGLE EYE PLATINUM ST CATHETER

Applicant Volcano Corporation

K number K120697

OBJ 2011-11-18

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

Applicant Biosense Webster, Inc.

K number K112050

OBJ 2011-08-04

ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER

Applicant Boston Scientific Corp

K number K111043

OBJ 2011-02-18

VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

Applicant Vasonova, Inc.

K number K103260

OBJ 2011-02-18

VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

Applicant Vasonova, Inc.

K number K103255

OBJ 2010-06-22

SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12

Applicant Biosense Webster, Inc.

K number K101138

OBJ 2009-12-10

EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

Applicant Volcano Corporation

K number K092596

OBJ 2009-12-04

SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

Applicant Biosense Webster, Inc.

K number K091352

OBJ 2009-08-07

SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12

Applicant Biosense Webster, Inc.

K number K092064

OBJ 2008-10-15

FLOWPICC CONSOLE

Applicant Vasonova, Inc.

K number K081626

OBJ 2008-09-26

ACUNAV V ULTRASOUND CATHETER

K number K081808

OBJ 2008-09-26

FLOWPICC STYLET

Applicant Vasonova, Inc.

K number K081625

OBJ 2008-05-12

REVOLUTION 45MHZ IVUS IMAGING CATHETER

Applicant Volcano Corporation

K number K080891

OBJ 2008-01-14

EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700

Applicant Volcano Corporation

K number K073473

OBJ 2008-01-04

VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM

Applicant Volcano Corporation

K number K071554

OBJ 2007-08-31

VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900

Applicant Volcano Corporation

K number K071660

OBJ 2007-06-29

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F

K number K071234

OBJ 2007-05-15

SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05

Applicant Biosense Webster, Inc.

K number K070242

OBJ 2005-08-18

EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001

Applicant Volcano Corporation

K number K051337

OBJ 2005-07-14

ILAB ULTRASOUND IMAGING SYSTEM

Applicant Boston Scientific Corp

K number K051679

OBJ 2005-06-20

REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER

Applicant Volcano Corporation

K number K050995

OBJ 2004-10-15

ACUSON ACUNAV 8F ULTRASOUND CATHETER

K number K042593

OBJ 2004-07-23

MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456

Applicant Boston Scientific Scimed, Inc.

K number K041727

OBJ 2004-06-02

COMBOMAP PRESSURE AND FLOW SYSTEM

Applicant Volcano Therapeutics, Inc.

K number K041134

OBJ 2004-02-24

ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER

K number K033650

OBJ 2003-06-23

JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900

Applicant Jomed, Inc.

K number K031346

OBJ 2003-03-03

CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN

Applicant Cd Leycom BV

K number K030524