FDA 510(k) Application Details - K042541

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K042541
Device Name	Catheter, Percutaneous
Applicant	CRYOVASCULAR SYSTEMS, INC. 160 KNOWLES DR. LOS GATOS, CA 95032 US Other 510(k) Applications for this Company
Contact	KIM TOMPKINS Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2004
Decision Date	10/12/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review