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FDA 510(k)

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

K-Number: K201181 · 2020-06-26

ApplicantABBOTT MEDICAL
Decision Date2020-06-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2020-06-26 under approval number K201181. 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 Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System?

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K201181.

When was EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System approved by the FDA?

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System received FDA 510(k) clearance on 2020-06-26, under approval number K201181.

What company makes EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System?

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System is manufactured by ABBOTT MEDICAL.

What is the FDA product code for EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System?

The FDA product code for EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System is DQK.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING

Related PubMed Literature

PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024)

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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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