FDA 510(k) Application Details - K091213

Device Classification Name	Catheter, Umbilical Artery   More FDA Info for this Device
510(K) Number	K091213
Device Name	Catheter, Umbilical Artery
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	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2009
Decision Date	09/25/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review