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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspiration thrombectomy catheter
510(k) Number K112571
Device Name XL EXTRACTION CATHETER
Applicant
VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis,  MN  55369
Applicant Contact MATT NIENSTEDT
Correspondent
VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis,  MN  55369
Correspondent Contact MATT NIENSTEDT
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received09/06/2011
Decision Date 10/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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