FDA 510(k) Application Details - K130507

Device Classification Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days   More FDA Info for this Device
510(K) Number	K130507
Device Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant	FOOTPRINT MEDICAL INC. 12727 CIMARRON PATH SAN ANTONIO, TX 78249 US Other 510(k) Applications for this Company
Contact	CLYDE N BAKER Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	LJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2013
Decision Date	06/03/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review