INFUSION CATHETER EXTENSION SET


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K023224
Device Name INFUSION CATHETER EXTENSION SET
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 09/27/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No