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FDA 510(k) Application Details - K081989
Device Classification Name
More FDA Info for this Device
510(K) Number
K081989
Device Name
MODIFICATION TO FETCH ASPIRATION CATHETER
Applicant
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 US
Other 510(k) Applications for this Company
Contact
MIKE BURNSIDE
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/14/2008
Decision Date
09/26/2008
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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