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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K223094
Device Name EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License
Applicant
Abbott Medical
One St. Jude Medical Device
St. Paul,  MN  55117
Applicant Contact Alyssa Timmers
Correspondent
Abbott Medical
One St. Jude Medical Device
St. Paul,  MN  55117
Correspondent Contact Alyssa Timmers
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/30/2022
Decision Date 12/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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