Scopis Hybrid Navigation System EM

FDA 510(k)

FDA Class 2 ·Neurology

Crosser iQ CTO Recanalization System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tigereye ST CTO-Crossing Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

WILDCAT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

StealthStationTM S8 ENT Software

FDA 510(k)

FDA Class 2 ·Neurology

TGS Guidewire and updated Scopis Software

FDA 510(k)

FDA Class 2 ·Neurology

SoundBite® Crossing System XS Peripheral

FDA 510(k)

FDA Class 2 ·Cardiovascular

CROSSER RECANALIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

FDA 510(k)

FDA Class 2 ·Neurology

PIONEER PLUS CATHETER, MODEL PLUS 120

FDA 510(k)

FDA Class 2 ·Cardiovascular

TruDi NAV Wire

FDA 510(k)

FDA Class 2 ·Neurology

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRUEPATH CTO DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELITECROSS Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D

FDA 510(k)

FDA Class 2 ·Neurology

MICRO GUIDE CATHETER XP

FDA 510(k)

FDA Class 2 ·Cardiovascular

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TGS Universal Headrest with Mounting Arm

FDA 510(k)

FDA Class 2 ·Neurology

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

FDA 510(k)

FDA Class 2 ·Neurology