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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 K101604
Device Name VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
Applicant
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Applicant Contact JENNIFER RUETHER
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Correspondent Contact JENNIFER RUETHER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/08/2010
Decision Date 01/24/2011
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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