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FDA 510(k) Application Details - K140286
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K140286
Device Name
Filter, Intravascular, Cardiovascular
Applicant
CORDIS, A JOHNSON & JOHNSON CO.
6500 PASEO PADRE PARKWAY
FREMONT, CA 94555 US
Other 510(k) Applications for this Company
Contact
SHAMSA KARIMI
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
02/05/2014
Decision Date
03/07/2014
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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