K252226 is an FDA 510(k) clearance for the Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101). This device is classified as a Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use (Class II - Special Controls, product code NQJ).
Submitted by Nuwellis, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 13, 2025, 28 days after receiving the submission on July 16, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540. Dual Lumen, Non-implanted, Peripheral Access Catheters Are Inserted In The Peripheral Arm Vein And Are Indicated For Temporary (up To 8 Hours) Ultrafiltration Treatment Of Patients With Fluid Overload..
| 510(k) Number | K252226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2025 |
| Decision Date | August 13, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NQJ - Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Dual Lumen, Non-implanted, Peripheral Access Catheters Are Inserted In The Peripheral Arm Vein And Are Indicated For Temporary (up To 8 Hours) Ultrafiltration Treatment Of Patients With Fluid Overload. |