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FDA 510(k)

CardioInsight Cardiac Mapping System

K-Number: K181918 · 2018-11-08

ApplicantMedtronic, Inc.
Decision Date2018-11-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioInsight Cardiac Mapping System is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2018-11-08 under approval number K181918. 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 CardioInsight Cardiac Mapping System?

CardioInsight Cardiac Mapping System is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Medtronic, Inc.. The 510(k) number is K181918.

When was CardioInsight Cardiac Mapping System approved by the FDA?

CardioInsight Cardiac Mapping System received FDA 510(k) clearance on 2018-11-08, under approval number K181918.

What company makes CardioInsight Cardiac Mapping System?

CardioInsight Cardiac Mapping System is manufactured by Medtronic, Inc..

What is the FDA product code for CardioInsight Cardiac Mapping System?

The FDA product code for CardioInsight 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 NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System 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 Medtronic, Inc.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162054Medtronic Temporary External Pacemaker 53401 K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement

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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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