FDA 510(k) Application Details - K131260

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K131260
Device Name	Catheter, Hemodialysis, Implanted
Applicant	NAVILYST MEDICAL, INC. 26 FOREST STREET MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	Lorraine M Hanley Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2013
Decision Date	02/14/2014
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