FDA 510(k) Application Details - K071529

Device Classification Name	More FDA Info for this Device
510(K) Number	K071529
Device Name	XTRACT CATHETER SYSTEM
Applicant	LUMEN BIOMEDICAL, INC. 14505 21ST AVE. NORTH SUITE 212 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	MARIA E BRITTLE 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	06/05/2007
Decision Date	08/10/2007
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