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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K073200
Device Name GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Applicant Contact JULIE TAPPER
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Correspondent Contact JULIE TAPPER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/13/2007
Decision Date 02/01/2008
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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