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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, electrode recording, or probe, electrode recording
510(k) Number K192037
Device Name Advisor VL Circular Mapping Catheter, Sensor Enabled
Applicant
Abbott Medical
5050 Nathan Lane North
plymouth,  MN  55442
Applicant Contact tamara l. stanczak
Correspondent
Abbott Medical
5050 Nathan Lane North
plymouth,  MN  55442
Correspondent Contact tamara l. stanczak
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/30/2019
Decision Date 09/17/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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