FDA 510(k) Application Details - K031005

Device Classification Name	More FDA Info for this Device
510(K) Number	K031005
Device Name	LUMEND FRONTRUNNER GW CTO CATHETER
Applicant	LUMEND, INC. 400 CHESAPEAKE DR. REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	MICHAEL A DANIEL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2003
Decision Date	06/18/2003
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