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FDA 510(k)

EnSite Precision Cardiac Mapping System v2.0

K-Number: K160210 · 2016-12-13

ApplicantSt Jude Medical
Decision Date2016-12-13
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite Precision Cardiac Mapping System v2.0 is a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2016-12-13 under approval number K160210. 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 Precision Cardiac Mapping System v2.0?

EnSite Precision Cardiac Mapping System v2.0 is a medical device that received FDA 510(k) clearance on 2016-12-13. It is manufactured by St Jude Medical. The 510(k) number is K160210.

When was EnSite Precision Cardiac Mapping System v2.0 approved by the FDA?

EnSite Precision Cardiac Mapping System v2.0 received FDA 510(k) clearance on 2016-12-13, under approval number K160210.

What company makes EnSite Precision Cardiac Mapping System v2.0?

EnSite Precision Cardiac Mapping System v2.0 is manufactured by St Jude Medical.

What is the FDA product code for EnSite Precision Cardiac Mapping System v2.0?

The FDA product code for EnSite Precision Cardiac Mapping System v2.0 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 St Jude Medical

K160218AutoMark Module K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D K162643MediGuide Technology System K161873Pacel Flow Directed Pacing Catheter K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 K160186EnSite Velocity Surface Electrode Kit

View all 13 devices →

Related Devices (Code: DQK)

K160218AutoMark ModuleSt 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 K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH

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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