FDA 510(k) Application Details - K140637

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K140637
Device Name	Catheter, Continuous Flush
Applicant	ABLATIVE SOLUTIONS, INC. 801 Hermosa Way Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	SHARON ROCKWELL Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2014
Decision Date	03/26/2014
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	Y
Expedited Review