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FDA 510(k)

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

K-Number: K183128 · 2018-12-12

ApplicantAbbott
Decision Date2018-12-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is a medical device manufactured by Abbott. It received FDA 510(k) clearance on 2018-12-12 under approval number K183128. 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 v5.2, EnSite Precision Cardiac Mapping System v2.2?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is a medical device that received FDA 510(k) clearance on 2018-12-12. It is manufactured by Abbott. The 510(k) number is K183128.

When was EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 approved by the FDA?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 received FDA 510(k) clearance on 2018-12-12, under approval number K183128.

What company makes EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is manufactured by Abbott.

What is the FDA product code for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

The FDA product code for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 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)

Other Devices by Abbott

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 K210392WorkMate Claris System

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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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