CARTO XP EP NAVIGATION SYSTEM, VERSION 9

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOSERVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System Version 7.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Precision Cardiac Mapping System v2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Velocity Surface Electrode Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVVIGO Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSUITE HEMODYNAMICS 7.10

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zio ECG Utilization Software (ZEUS) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATHCOR DESKTOP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP MEDSYSTEMS, EP-WORKMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Q5000 PC WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENDYS, MODEL 6000 B B/C

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPRESARIO

FDA 510(k)

FDA Class 2 ·Cardiovascular