FDA 510(k) Application Details - K173533

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K173533
Device Name	Catheter, Retention Type, Balloon
Applicant	Poiesis Medical, LLC 1095 Jupiter Park Drive Suite 10 Jupiter, FL 33458 US Other 510(k) Applications for this Company
Contact	Greg Wiita 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	11/15/2017
Decision Date	03/29/2018
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