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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K091750
Device Name GUIDELINER CATHETER, MODELS 5571, 5572, 5573
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Applicant Contact LOUCINDA BJORKLUND
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Correspondent Contact LOUCINDA BJORKLUND
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/16/2009
Decision Date 11/04/2009
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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