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FDA 510(k)

EnSite X EP System

K-Number: K221213 · 2022-08-18

ApplicantAbbott
Decision Date2022-08-18
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 2022-08-18 under approval number K221213. 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 2022-08-18. It is manufactured by Abbott. The 510(k) number is K221213.

When was EnSite X EP System approved by the FDA?

EnSite X EP System received FDA 510(k) clearance on 2022-08-18, under approval number K221213.

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.

Related Clinical Trials

NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT04483089 An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT) ACTIVE_NOT_RECRUITING NCT07250828 Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy ENROLLING_BY_INVITATION NCT06647576 Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs COMPLETED NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06083038 Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib COMPLETED

Related PubMed Literature

PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by Abbott

K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 K192593Confirm Rx Insertable Cardiac Monitor K190167MitraClip G4 Steerable Guide Catheter K182981Confirm Rx Insertable Cardiac Monitor K212061EnSite X EP System

View all 13 devices →

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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