FDA 510(k) Application Details - K062275

Device Classification Name	More FDA Info for this Device
510(K) Number	K062275
Device Name	RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
Applicant	KERBEROS PROXIMAL SOLUTIONS, INC. 10600 NORTH TANTAU AVE. CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	TOM MASON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2006
Decision Date	09/20/2006
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review