FDA 510(k) Application Details - K222279

Device Classification Name	Catheter, Coude   More FDA Info for this Device
510(K) Number	K222279
Device Name	Catheter, Coude
Applicant	Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Kelly Breheim Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2022
Decision Date	08/29/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review