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FDA 510(k) Applications Submitted by Brenda Clay
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170819
03/20/2017
AcQMap 3D Imaging and Mapping Catheter
Acutus Medical, Inc.
K170948
03/30/2017
AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
K171557
05/30/2017
AcQRef Introducer Sheath
Acutus Medical, Inc.
K102588
09/09/2010
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
MEDTRONIC ABLATION FRONTIERS, LLC
K162925
10/19/2016
AcQGuide Steerable Sheath
ACUTUS MEDICAL, INC.
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