FDA 510(k) Application Details - K052232

Device Classification Name

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510(K) Number K052232
Device Name VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
Applicant VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS, MN 55369 US
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Contact SARA L COON
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Regulation Number

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Classification Product Code QEZ
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Date Received 08/17/2005
Decision Date 09/28/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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