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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K905674
Device Name LEAD STYLET
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Applicant Contact STEPHAN NORSTED
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Correspondent Contact STEPHAN NORSTED
Regulation Number870.1380
Classification Product Code
DRB  
Date Received12/18/1990
Decision Date 01/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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