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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
510(k) Number K041791
Device Name 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
Applicant
Chf Solutions, Inc.
7601 Northland Dr. Suite 170
Brooklyn Park Mn,  MN  55428
Applicant Contact AMY PETERSON
Correspondent
Chf Solutions, Inc.
7601 Northland Dr. Suite 170
Brooklyn Park Mn,  MN  55428
Correspondent Contact AMY PETERSON
Regulation Number876.5540
Classification Product Code
NQJ  
Date Received07/02/2004
Decision Date 09/10/2004
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
Predetermined Change
Control Plan Authorized		 No
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