Abbott Medical - FDA 510(k) Cleared Devices

Cleared Jul 15, 2026

EnSite™ X EP System

K262006 · DQK

Cardiovascular · 30d

Cleared Jun 17, 2026

Amplatzer TorqVue Exchange System

K261631 · DQY

Cardiovascular · 30d

Cleared CT Apr 24, 2026

OPTIS Mobile Next Imaging System (1014932)

K253459 · NQQ

Cardiovascular · 199d

Cleared Apr 20, 2026

EnSite™ X EP System

K260212 · DQK

Cardiovascular · 87d

Cleared Mar 13, 2026

Amplatzer™ Trevisio™ Intravascular Delivery System

K260499 · DQY

Cardiovascular · 28d

Cleared Feb 13, 2026

Armada™ 14 NC PTA Catheter

K252512 · LIT

Cardiovascular · 186d

Cleared Dec 18, 2025

Assert-IQ (DM5100)

K253516 · MXD

Cardiovascular · 36d

Cleared Dec 17, 2025

Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)

K252417 · DQY

Cardiovascular · 138d

Cleared Oct 29, 2025

Seguin Annuloplasty Ring

K253232 · KRH

Cardiovascular · 30d

Cleared Oct 03, 2025

Amplatzer Guidewire

K250031 · DQX

Cardiovascular · 269d

Cleared Sep 25, 2025

EnSite™ X EP System

K252013 · DQK

Cardiovascular · 90d

Cleared Sep 04, 2025

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01)

K251463 · DQK

Cardiovascular · 115d