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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