FDA 510(k) Application Details - K041123

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K041123
Device Name	Catheter, Intravascular, Diagnostic
Applicant	KERBEROS PROXIMAL SOLUTIONS, INC. 1400 TERRA BELLA AVE, SUITE K MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	TOM MASON Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2004
Decision Date	08/26/2004
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review