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

AcuNav Volume ICE Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCross 18, 30 MHz Peripheral Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcuNav V 10F Ultrasound Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUNAV V ULTRASOUND CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular