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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K153093
Device Name FIRMap Catheter
Applicant
Abbott Electrophysiology
1530 Obrien Dr., Suite B
Menlo Park,  CA  94025
Applicant Contact DENNIS POZZO
Correspondent
Abbott Electrophysiology
3668 S. Geyer Rd.
Suite 365
St.Louis,  MO  63127
Correspondent Contact DENNIS POZZO
Regulation Number870.1220
Classification Product Code
MTD  
Date Received10/26/2015
Decision Date 04/07/2016
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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