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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 K051395
Device Name LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
Applicant
VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS,  MN  55369
Applicant Contact SARA L COON
Correspondent
VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS,  MN  55369
Correspondent Contact SARA L COON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/27/2005
Decision Date 06/24/2005
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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