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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 K202066
Device Name EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
Applicant
Abbott Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Applicant Contact Alyssa Timmers
Correspondent
Abbott Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Correspondent Contact Alyssa Timmers
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DRF   MTD  
Date Received07/27/2020
Decision Date 11/25/2020
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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