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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

ABBOTT MEDICAL · Class II · Cleared Nov 25, 2020

K-numberK202066
Device nameEnSite 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
ApplicantABBOTT MEDICAL
Product codeDQK
Device classClass II
Decision dateNov 25, 2020
DecisionSubstantially Equivalent
Regulation870.1425
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