FDA 510(k) Application Details - K031689

Device Classification Name	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use   More FDA Info for this Device
510(K) Number	K031689
Device Name	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Applicant	CHF SOLUTIONS, INC. SUITE 170-7601 NORTHLAND DR. BROOKLYN PARK, MN 55428 US Other 510(k) Applications for this Company
Contact	AMY PETERSON Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2003
Decision Date	12/23/2003
Decision	SESE - SUBST EQUIV
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