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FDA 510(k) Application Details - K093911
Device Classification Name
Catheter, Intravascular Occluding, Temporary
More FDA Info for this Device
510(K) Number
K093911
Device Name
Catheter, Intravascular Occluding, Temporary
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614 US
Other 510(k) Applications for this Company
Contact
PATRICIA A MILBANK
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2009
Decision Date
01/21/2010
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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