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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 K052257
FOIA Releasable 510(k) K052257
Device Name VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS 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 Number870.1250
Classification Product Code
DQY  
Date Received08/18/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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