CardioInsight Cardiac Mapping System

Computer, Diagnostic, Programmable

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Cardioinsight Cardiac Mapping System.

Pre-market Notification Details

Device IDK181918
510k NumberK181918
Device Name:CardioInsight Cardiac Mapping System
ClassificationComputer, Diagnostic, Programmable
Applicant Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactJanell Colley
CorrespondentJanell Colley
Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-18
Decision Date2018-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000118280 K181918 000

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