MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STARCLOSE HEX-HUB DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOXCROSS PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE POWERTURN

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

NC TREK RX CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Abbott Vascular International BVBA

Authorized representative

🇧🇪 Belgium·3 Manufacturers

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEMS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems; XIENCE Xpedition, XIENCE Xpedition SV, XIENCE X