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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 K080924
Device Name MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact COLLEEN CANAN
Correspondent
St. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact COLLEEN CANAN
Regulation Number870.1380
Classification Product Code
DRB  
Date Received04/02/2008
Decision Date 04/30/2008
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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