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FDA 510(k)

CardioInsight Cardiac Mapping System

K-Number: K162440 · 2016-11-04

ApplicantCardioinsight Technologies, Inc.
Decision Date2016-11-04
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioInsight Cardiac Mapping System is a medical device manufactured by Cardioinsight Technologies, Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K162440. 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 2016-11-04. It is manufactured by Cardioinsight Technologies, Inc.. The 510(k) number is K162440.

When was CardioInsight Cardiac Mapping System approved by the FDA?

CardioInsight Cardiac Mapping System received FDA 510(k) clearance on 2016-11-04, under approval number K162440.

What company makes CardioInsight Cardiac Mapping System?

CardioInsight Cardiac Mapping System is manufactured by Cardioinsight Technologies, 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: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

Related Devices (Code: DQK)

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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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