Medical Device Manufacturer · US , St. Paul , MN

Abbott - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2018

Official Website

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Cardiovascular ✕

11 devices

1-11 of 11

Cleared Apr 24, 2026

Amplatzer TorqVue Delivery System

Cardiovascular · 29d

Cleared Sep 17, 2025

Assert-IQ (DM5000)

Cardiovascular · 149d

Cleared Dec 01, 2022

CentriMag Pre-connected Pack

Cardiovascular · 122d

Cleared Aug 18, 2022

EnSite X EP System

Cardiovascular · 113d

Cleared Oct 22, 2021

EnSite X EP System

Cardiovascular · 113d

Cleared Mar 11, 2021

WorkMate Claris System

Cardiovascular · 29d

Cleared Oct 18, 2019

Confirm Rx Insertable Cardiac Monitor

Cardiovascular · 28d

Cleared May 29, 2019

MitraClip G4 Steerable Guide Catheter

Cardiovascular · 118d

Cleared Mar 29, 2019

Confirm Rx Insertable Cardiac Monitor

Cardiovascular · 151d

Cleared Dec 12, 2018

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...

Cardiovascular · 29d

Cleared Oct 19, 2018

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...

Cardiovascular · 25d