EnSite X EP System
K-Number: K251234 · 2025-07-30
ApplicantABBOTT MEDICAL
Decision Date2025-07-30
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 2025-07-30 under approval number K251234. 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 2025-07-30. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K251234.
When was EnSite X EP System approved by the FDA?
EnSite X EP System received FDA 510(k) clearance on 2025-07-30, under approval number K251234.
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.
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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.