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FDA 510(k) Application Details - K081410
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K081410
Device Name
Filter, Intravascular, Cardiovascular
Applicant
REX MEDICAL
386 W. MAIN STREET
SUITE 7
NORTHBOROUGH, MA 01532 US
Other 510(k) Applications for this Company
Contact
LEO BASTA
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
05/20/2008
Decision Date
06/04/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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