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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 K061565
Device Name LANGSTON DUAL LUMEN CATHETER
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 Received06/05/2006
Decision Date 08/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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