FDA 510(k) Application Details - K121301

Device Classification Name	More FDA Info for this Device
510(K) Number	K121301
Device Name	XPRESSWAY RX CATHETER (6F LD-VERISON)
Applicant	KANEKA PHARMA AMERICA LLC 546 FIFTH AVE., 21ST FLOOR NEW YORK, NY 10036 US Other 510(k) Applications for this Company
Contact	JOSEPH DEPAOLO 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	05/01/2012
Decision Date	07/30/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review