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FDA 510(k) Application Details - K062887
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K062887
Device Name
Filter, Intravascular, Cardiovascular
Applicant
BARD PERIPHERAL VASCULAR
1625 WEST 3RD ST.
PO BOX 1740
TEMPE, AZ 85280-1740 US
Other 510(k) Applications for this Company
Contact
GENEVIEVE BALUTOWSKI
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
09/26/2006
Decision Date
10/26/2006
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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