FDA 510(k) Application Details - K102605

Device Classification Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted   More FDA Info for this Device
510(K) Number	K102605
Device Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Applicant	COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA 15 HAMPSHIRE ST. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	Daniel Campion Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2010
Decision Date	12/22/2010
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