Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYSTEMS (OAS)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360™ Coronary Orbital Atherectomy System, Diamondback 360 Precision™ Coronary Orbital Atherectomy System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown

CVIS INSIGHT IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CVIS INSIGHT IMAGING GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CVIS INSIGHT IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOMATIC PULL BACK DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CVIS INSIGHT IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROVIEW II/MICRORAIL II CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CVIS INSIGHT III SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CVIS LONGVIEW

FDA 510(k)

FDA Class 2 ·Cardiovascular

CVIS INSIGHT IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CVIS INSIGHT IMAGING CATHETERS

FDA 510(k)

FDA Class 2 ·Radiology

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE

FDA 510(k)

FDA Class 2 ·Radiology

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL

FDA 510(k)

FDA Class 2 ·Radiology

CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE

FDA 510(k)

FDA Class 2 ·Radiology

CVIS ULTRA-SCAN ONE IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CVIS ULTRA-SCAN ONE IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Radiology

BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/

FDA 510(k)

FDA Class 2 ·Radiology