FDA 510(k) Application Details - K112571

Device Classification Name

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510(K) Number K112571
Device Name XL EXTRACTION CATHETER
Applicant VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis, MN 55369 US
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Contact MATT NIENSTEDT
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Regulation Number

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Classification Product Code QEZ
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Date Received 09/06/2011
Decision Date 10/06/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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