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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K042623
Device Name AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
Applicant
ST. JUDE MEDICAL, DAIG DIVISION, INC.
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Applicant Contact JENNIFER NEVISON
Correspondent
ST. JUDE MEDICAL, DAIG DIVISION, INC.
14901 DEVEAU PL.
MINNETONKA,  MN  55345 -2126
Correspondent Contact JENNIFER NEVISON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/27/2004
Decision Date 01/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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