FDA 510(k) Application Details - K153655

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K153655
Device Name	Catheter, Retention Type, Balloon
Applicant	POTRERO MEDICAL, INC. 101 MISSISSIPPI ST. SAN FRANCISCO, CA 94107 US Other 510(k) Applications for this Company
Contact	DEVYANI NANDURI Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2015
Decision Date	04/15/2016
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review