AcQMap 3D Imaging And Mapping Catheter

Catheter, Intracardiac Mapping, High-density Array

Acutus Medical, Inc.

The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqmap 3d Imaging And Mapping Catheter.

Pre-market Notification Details

Device IDK201341
510k NumberK201341
Device Name:AcQMap 3D Imaging And Mapping Catheter
ClassificationCatheter, Intracardiac Mapping, High-density Array
Applicant Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad,  CA  92008
ContactKarla Schaffner
CorrespondentKarla Schaffner
Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad,  CA  92008
Product CodeMTD  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-09-15

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