FDA 510(k) Application Details - K212077

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K212077
Device Name	Catheter, Retention Type, Balloon
Applicant	Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Kelley Breheim 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	07/02/2021
Decision Date	07/27/2023
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