SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K024124
Device Name SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
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  
Date Received 12/16/2002
Decision Date 03/14/2003
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