FDA 510(k) Application Details - K041791

Device Classification Name	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use   More FDA Info for this Device
510(K) Number	K041791
Device Name	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Applicant	CHF SOLUTIONS, INC. 7601 NORTHLAND DR. STE. 170 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	07/02/2004
Decision Date	09/10/2004
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