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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 K081645
Device Name AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Applicant Contact MAC MCKEEN
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Correspondent Contact MAC MCKEEN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/12/2008
Decision Date 12/09/2008
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
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