HI-TORQUE VERSACORE GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE VERSATURN GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

.035 LOC GUIDE WIRE EXTENSION

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE PROCEED Guide Wire Family

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARMADA 14XXT PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hi-Torque Command 18 Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE InfilTrac Guide Wire Family

FDA 510(k)

FDA Class 2 ·Cardiovascular

Armada 18 PTA Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE Steelcore Bare Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOX SV PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

RX ACCUNET Embolic Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular