Medical Device Manufacturer · US , S,Mta Clara , CA

Abbott Medical - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 2019

Recent clearances: EnSite™ X EP System, EnSite™ X EP System, Amplatzer TorqVue Exchange System

View 60 510(k) Devices ↓ Official Website
60
Total
60
Cleared
0
Denied

FDA 510(k) Regulatory Record - Abbott Medical Cardiovascular ✕

56 devices
1-12 of 56
Cleared Sep 17, 2026
EnSite™ X EP System
K261729 · DQK
Cardiovascular · 114d
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

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