FDA 510(k) Application Details - K101599

Device Classification Name	More FDA Info for this Device
510(K) Number	K101599
Device Name	RVT CTO DEVICE
Applicant	REVASCULAR THERAPEUTICS, INC. 766 PALOMAR AVENUE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	NANCY LINCE 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	06/07/2010
Decision Date	01/18/2011
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