SYSTEM 100 ULTRAFILTRATION CATHETER


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K023874
Device Name SYSTEM 100 ULTRAFILTRATION CATHETER
Original Applicant
CHF SOLUTIONS, INC.
suite 170-7601 northland dr.
brooklyn park, 
MN 
55428

Original Contact amy peterson
Regulation Number 876.5860
Classification Product Code
KDI  
Subsequent Product Code
MPB  
Date Received 11/21/2002
Decision Date 11/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No