EnSite X EP System
K-Number: K260212 · 2026-04-20
ApplicantABBOTT MEDICAL
Decision Date2026-04-20
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EnSite X EP System is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-04-20 under approval number K260212. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EnSite X EP System?
EnSite X EP System is a medical device that received FDA 510(k) clearance on 2026-04-20. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K260212.
When was EnSite X EP System approved by the FDA?
EnSite X EP System received FDA 510(k) clearance on 2026-04-20, under approval number K260212.
What company makes EnSite X EP System?
EnSite X EP System is manufactured by ABBOTT MEDICAL.
What is the FDA product code for EnSite X EP System?
The FDA product code for EnSite X EP System is DQK.
Related Clinical Trials
Other Devices by ABBOTT MEDICAL
K192267ILUMIEN System with AptiVue Software version D.3
K192019Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
K192037Advisor VL Circular Mapping Catheter, Sensor Enabled
K190581Amplatzer Trevisio Intravascular Delivery System
K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
K201610IonicRF Generator
Related Devices (Code: DQK)
K160218AutoMark ModuleSt Jude Medical
K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical
K162643MediGuide Technology SystemSt Jude Medical
K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.
K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical
K160186EnSite Velocity Surface Electrode KitSt Jude Medical
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.