CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit

FDA 510(k)

FDA Class 2 ·Radiology

STERILE EQUIPMENT COVERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VOLCANO IFR MODALITY

FDA 510(k)

FDA Class 2 ·Radiology

VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz

FDA 510(k)

FDA Class 2 ·Radiology

S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE

FDA 510(k)

FDA Class 2 ·Radiology

CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

FDA 510(k)

FDA Class 2 ·Cardiovascular

VALET MICRO CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EAGLE EYE PLATINUM ST CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

IntraSight Mobile

FDA 510(k)

FDA Class 2 ·Radiology

EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Volcano Visions PV .018 Digital IVUS Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

FDA 510(k)

FDA Class 2 ·Cardiovascular

IN VISION GOLD WITH SPIN VISION, MODEL 891 SV

FDA 510(k)

FDA Class 2 ·Radiology

EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001

FDA 510(k)

FDA Class 2 ·Radiology

Verrata PLUS Pressure Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular