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 |
|