Abbott Medical - FDA 510(k) Cleared Devices

Cleared Jun 08, 2021

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

K210458 · NQQ

Cardiovascular · 112d

Cleared Nov 25, 2020

EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled,...

K202066 · DQK

Cardiovascular · 121d

Cleared Oct 21, 2020

IonicRF Generator

K201610 · GXD

Neurology · 128d

Cleared Jun 26, 2020

EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software...

K201148 · DQK

Cardiovascular · 58d

Cleared Jun 26, 2020

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

K201181 · DQK

Cardiovascular · 57d

Cleared Dec 17, 2019

ILUMIEN System with AptiVue Software version D.3

K192267 · DQO

Cardiovascular · 118d

Cleared Nov 08, 2019

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1

K192019 · DQO

Cardiovascular · 102d

Cleared Sep 17, 2019

Advisor VL Circular Mapping Catheter, Sensor Enabled

K192037 · DRF

Cardiovascular · 49d

Cleared Apr 05, 2019

Amplatzer Trevisio Intravascular Delivery System

K190581 · DQY

Cardiovascular · 30d