ACS INDEFLATOR (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BRACHIAL CORONARY GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS SCHWARTEN XT BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

WHOLEY HI-TORQUE GUIDE WIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTCA BALLOON CATHETERS & ACCESS.

FDA 510(k)

.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BALLOON DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTW MEGALINK SDS BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MULTIPURPOSE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD)