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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 K142182
Device Name FRIMAP ADAPTER CONNECTOR (MAC)
Applicant
Topera, Inc.
3668 S. Geyer Rd.
Suite 365
St.Louis,  MO  63127
Applicant Contact DENNIS POZZO
Correspondent
Topera, Inc.
3668 S. Geyer Rd.
Suite 365
St.Louis,  MO  63127
Correspondent Contact DENNIS POZZO
Regulation Number870.1220
Classification Product Code
MTD  
Date Received08/08/2014
Decision Date 09/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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