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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 K062877
Device Name TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
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 Received09/26/2006
Decision Date 01/18/2007
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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