VYGON MICRO-ACCESS SAFETY INTRODUCER KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL LINQ INSERTABLE CARDIAC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Peerbridge Cor(TM) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bandit guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FREEWAY AND RAILRUNNER GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Gallant PTCA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

CES INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lumax Guiding Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FFRangio

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDENTEC MODEL 4700 SCANNER

FDA 510(k)

FDA Class 1 ·Cardiovascular

Zio AT® device (A100A1001)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IntraSight Mobile

FDA 510(k)

FDA Class 2 ·Radiology

INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRAMSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular