FDA 510(k) Application Details - K031842

Device Classification Name	More FDA Info for this Device
510(K) Number	K031842
Device Name	SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Applicant	INTRALUMINAL THERAPEUTICS, INC. 6354 CORTE DEL ABETO SUITE A CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	PAMELA MISAJON 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	06/16/2003
Decision Date	11/21/2003
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