FDA 510(k) Application Details - K112477

Device Classification Name	Catheter, Hemodialysis, Implanted, Coated   More FDA Info for this Device
510(K) Number	K112477
Device Name	Catheter, Hemodialysis, Implanted, Coated
Applicant	COVIDIEN 15 HAMPSHIRE STREET MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	WING NG Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NYU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2011
Decision Date	09/28/2011
Decision	SESK - SUBST EQUIV - KIT
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