FDA 510(k) Application Details - K201155

Device Classification Name	More FDA Info for this Device
510(K) Number	K201155
Device Name	PleurX Peritoneal Catheter System
Applicant	CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 US Other 510(k) Applications for this Company
Contact	Nazeer Khan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2020
Decision Date	10/21/2020
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