FDA 510(k) Application Details - K221020

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K221020
Device Name	Catheter, Retention Type, Balloon
Applicant	Potrero Medical, Inc. 26142 Eden Landing Road Hayward, CA 94545 US Other 510(k) Applications for this Company
Contact	Priscila Tapia 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	04/06/2022
Decision Date	01/13/2023
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