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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 K161873
Device Name Pacel Flow Directed Pacing Catheter
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact Blair Schwartz
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact Blair Schwartz
Regulation Number870.3680
Classification Product Code
LDF  
Date Received07/07/2016
Decision Date 11/22/2016
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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