CROSSER RECANALIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PIONEER PLUS CATHETER, MODEL PLUS 120

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

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

SoundBite Console, SoundBite Active Wire 18

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15

FDA 510(k)

FDA Class 2 ·Cardiovascular

PIONEER PLUS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

RVT CTO DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RA-308 Excimer Laser System, Excimer Laser Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO THE CROSSER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CROSSER CTO Recanalization Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OCELOT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PowerWire Radiofrequency Guidewire Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter For Crossing Total Occlusions

FDA classification

FDA Class 2 ·Catheter For Crossing Total Occlusions

VERTIX 3D-U

FDA 510(k)

FDA Class 2 ·Radiology

ARTERIAL DIAGNOSTIC UNIT (ADU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TNS MK I STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology