NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ILAB ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visions PV .035 Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

NUVISION™ NAV Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLOWPICC CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HD-IVUS ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

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)

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIEWFLEX XTRA ICE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

NuVision ICE Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViewFlex Xtra ICE Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTICROSS 40 MHZ CORONARY IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular