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FDA 510(k) Application Details - K071514
Device Classification Name
More FDA Info for this Device
510(K) Number
K071514
Device Name
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
Applicant
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 US
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Contact
FRANK B FREEDMAN
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2007
Decision Date
07/31/2007
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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