FDA 510(k) Application Details - K230400

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K230400
Device Name	Catheter, Straight
Applicant	ConvaTec, Inc. 7815 National Service Road, Suite 600 Greensboro, NC 27409 US Other 510(k) Applications for this Company
Contact	Courtney Smith Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2023
Decision Date	11/08/2023
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