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FDA 510(k)

EnSite X EP System

K-Number: K212061 · 2021-10-22

ApplicantAbbott
Decision Date2021-10-22
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite X EP System is a medical device manufactured by Abbott. It received FDA 510(k) clearance on 2021-10-22 under approval number K212061. 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 2021-10-22. It is manufactured by Abbott. The 510(k) number is K212061.

When was EnSite X EP System approved by the FDA?

EnSite X EP System received FDA 510(k) clearance on 2021-10-22, under approval number K212061.

What company makes EnSite X EP System?

EnSite X EP System is manufactured by Abbott.

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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Other Devices by Abbott

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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.

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