FDA 510(k) Application Details - K180485

Device Classification Name	Catheter, Peritoneal, Long-Term Indwelling   More FDA Info for this Device
510(K) Number	K180485
Device Name	Catheter, Peritoneal, Long-Term Indwelling
Applicant	Covidien, llc 15 Hampshire Street Mansfield, MA 02048 US Other 510(k) Applications for this Company
Contact	Carol Ming Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	FJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2018
Decision Date	07/27/2018
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