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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K160260
Device Name Tempo Temporary Pacing Lead
Applicant
Biotrace Medical, Inc.
831 Bransten Rd.
Suite L
San Carlos,  CA  94070
Applicant Contact Laura N. Dietch
Correspondent
Biotrace Medical, Inc.
831 Bransten Rd.
Suite L
San Carlos,  CA  94070
Correspondent Contact Laura N. Dietch
Regulation Number870.3680
Classification Product Code
LDF  
Date Received02/01/2016
Decision Date 10/25/2016
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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