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FDA 510(k) Application Details - K143208
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K143208
Device Name
Filter, Intravascular, Cardiovascular
Applicant
C.R. Bard, Inc
1625 W. Third St.
Tempe, AZ 85281 US
Other 510(k) Applications for this Company
Contact
Laurie Sang
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
11/10/2014
Decision Date
12/09/2014
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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