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FDA 510(k) Applications Submitted by Abbott
FDA 510(k) Number
Submission Date
Device Name
Applicant
K221213
04/27/2022
EnSite X EP System
Abbott
K182644
09/24/2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Abbott
K183128
11/13/2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Abbott
K210392
02/10/2021
WorkMate Claris System
Abbott
K190167
01/31/2019
MitraClip G4 Steerable Guide Catheter
Abbott
K212061
07/01/2021
EnSite X EP System
Abbott
K222297
08/01/2022
CentriMag Pre-connected Pack
Abbott
K192593
09/20/2019
Confirm Rx Insertable Cardiac Monitor
Abbott
K182981
10/29/2018
Confirm Rx Insertable Cardiac Monitor
Abbott
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