FDA 510(k) Applications for Medical Device Product Code "NQJ"
(Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use)

FDA 510(k) Number Applicant Device Name Decision Date
K041791 CHF SOLUTIONS, INC. 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) 09/10/2004
K031689 CHF SOLUTIONS, INC. DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) 12/23/2003
K233515 Nuwellis Inc. Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) 12/26/2023


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