FDA 510(k) Application Details - K023114

Device Classification Name	More FDA Info for this Device
510(K) Number	K023114
Device Name	LUMEND FRONTRUNNER 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	09/19/2002
Decision Date	01/23/2003
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