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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