Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE Sierra Everolimus Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE

Viatrac 14 Plus Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARMADA 35/35LL PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE TurnTrac Guide Wire Family

FDA 510(k)

FDA Class 2 ·Cardiovascular

TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hi-Torque Command 18 Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

STEERABLE GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

NC TREK OTW CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

FDA 510(k)

FDA Class 2 ·Cardiovascular

NC TREK NEO Coronary Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAD AND TAD II TAPERED GUIDE WIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE BALANCE

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular