Abbott Medical - FDA 510(k) Cleared Devices

Cleared Aug 10, 2023

EnSite™ X EP System

K231415 · DQK

Cardiovascular · 86d

Cleared Jun 30, 2023

ViewFlex™ Eco Reprocessed ICE Catheter

K231588 · OWQ

Cardiovascular · 29d

Cleared Jun 02, 2023

CPS Direct™ Universal slittable outer guide catheter (DS2C029)

K231311 · DQY

Cardiovascular · 28d

Cleared May 17, 2023

Assert-IQ™ Insertable Cardiac Monitor

K230286 · MXC

Cardiovascular · 104d

Cleared May 03, 2023

ViewFlex™ Eco Reprocessed ICE Catheter

K230934 · OWQ

Cardiovascular · 30d

Cleared Apr 14, 2023

Dragonfly OpStar™ Imaging Catheter

K230411 · DQO

Cardiovascular · 58d

Cleared Mar 01, 2023

Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120,...

K230283 · DYB

Cardiovascular · 28d

Cleared Dec 27, 2022

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software...

K223094 · DQK

Cardiovascular · 88d

Cleared Dec 19, 2022

ViewFlex Xtra Reprocessed ICE Catheter

K222217 · OWQ

Cardiovascular · 147d

Cleared Sep 28, 2022

MitraClip G4 Steerable Guide Catheter

K221397 · DRA

Cardiovascular · 138d

Cleared Jun 30, 2022

CPS AIM Universal II Slittable Inner Catheter

K221750 · DQY

Cardiovascular · 14d

Cleared Apr 30, 2022

Ultiri Measurement System

K220243 · DQK

Cardiovascular · 92d

Cleared Apr 01, 2022

Aveir Retrieval Catheter

K213494 · MMX

Cardiovascular · 151d

Cleared Mar 09, 2022

Amplatzer Steerable Delivery Sheath

K220340 · DQY

Cardiovascular · 30d

Cleared Nov 11, 2021

EnSite X EP System

K213364 · DQK

Cardiovascular · 30d

Cleared Sep 27, 2021

Amplatzer Steerable Delivery Sheath

K212026 · DQY

Cardiovascular · 90d

Cleared Sep 27, 2021

Amplatzer Talisman Delivery Sheath

K212738 · DQY

Cardiovascular · 28d

Cleared Jul 27, 2021

Aveir Introducer

K211989 · DYB

Cardiovascular · 29d

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 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