FDA 510(k) Application Details - DEN130044

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130044
Device Name	INFLOW INTRAURETHRAL VALVE-PUMP
Applicant	VESIFLO, INC. 8672 154th Ave NE Redmond, WA 98052 US Other 510(k) Applications for this Company
Contact	KEVIN M CONNOLLY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2013
Decision Date	10/14/2014
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review