FDA 510(k) Application Details - K050794

Device Classification Name

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510(K) Number K050794
Device Name ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
Applicant POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 US
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Contact MARK STENOIEN
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Regulation Number

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Classification Product Code QEZ
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Date Received 03/29/2005
Decision Date 04/28/2005
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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