FDA 510(k) Application Details - K040139

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K040139
Device Name	Catheter, Continuous Flush
Applicant	ENDOBIONICS, INC. 3077 TEAGARDEN STREET SAN LEANDRO, CA 94577-5720 US Other 510(k) Applications for this Company
Contact	KIRK P SEWARD Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2004
Decision Date	02/18/2004
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	Y
Expedited Review