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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 K061363
Device Name AGILIS NXT STEERABLE INTRODUCER
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact GLENN JACQUES
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact GLENN JACQUES
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/16/2006
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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