FDA 510(k) Application Details - K053372

Device Classification Name	More FDA Info for this Device
510(K) Number	K053372
Device Name	LBI CATHETER SYSTEM
Applicant	LUMEN BIOMEDICAL, INC. 2605 FERNBROOK LANE SUITE A PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	AMY PETERSON 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	12/05/2005
Decision Date	06/30/2006
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	N
Expedited Review