FDA 510(k) Application Details - K181616

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K181616
Device Name	Catheter, Retention Type, Balloon
Applicant	Pathway, LLC 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 US Other 510(k) Applications for this Company
Contact	David Stroup 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	06/19/2018
Decision Date	09/21/2018
Decision	SESE - SUBST EQUIV
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