FDA 510(k) Application Details - K060327

Device Classification Name Catheter, Percutaneous

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510(K) Number K060327
Device Name Catheter, Percutaneous
Applicant VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS, MN 55369 US
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Contact JULIE TAPPER
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 02/09/2006
Decision Date 04/12/2006
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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