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FDA 510(k) Application Details - K093026
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K093026
Device Name
Introducer, Catheter
Applicant
FOOTPRINT MEDICAL
1203 CAMDEN ST.
SAN ANTONIO, TX 78215 US
Other 510(k) Applications for this Company
Contact
CLYDE BAKER
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2009
Decision Date
02/24/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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