Abbott Medical - FDA 510(k) Cleared Devices

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

Cleared Jul 30, 2025

EnSite™ X EP System

K251234 · DQK

Cardiovascular · 99d

Cleared Jul 25, 2025

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

K250552 · DQX

Cardiovascular · 150d

Cleared May 23, 2025

ViewFlex™ Xtra ICE Catheter

K251211 · OBJ

Cardiovascular · 35d

Cleared May 20, 2025

ViewFlex™ X ICE Catheter, Sensor Enabled™

K251231 · OBJ

Cardiovascular · 28d