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FDA 510(k) Application Details - K121057
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K121057
Device Name
Filter, Intravascular, Cardiovascular
Applicant
WILLIAM COOK EUROPE APS
ONE GEDDES WAY
WEST LAFAYETTE, IN 47906 US
Other 510(k) Applications for this Company
Contact
Jennifer Brown
Other 510(k) Applications for this Contact
Regulation Number
870.3375
More FDA Info for this Regulation Number
Classification Product Code
DTK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2012
Decision Date
05/04/2012
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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