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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 K233515
Device Name Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Applicant
Nuwellis, Inc.
12988 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact Dawn Li
Correspondent
Nuwellis, Inc.
12988 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact Dawn Li
Regulation Number876.5540
Classification Product Code
NQJ  
Subsequent Product Codes
LJS   MPB   MSD   PND  
Date Received11/01/2023
Decision Date 12/26/2023
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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