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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 K070166
Device Name STRADA CAROTID GUIDING SHEATH
Applicant
St Jude Medical
6550 Wedgwood Rd. N.
Suite 150
Maple Grove,  MN  55311
Applicant Contact JEFF STURM
Correspondent
St Jude Medical
6550 Wedgwood Rd. N.
Suite 150
Maple Grove,  MN  55311
Correspondent Contact JEFF STURM
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/18/2007
Decision Date 04/06/2007
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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