K233515 is an FDA 510(k) clearance for the Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102). 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 December 26, 2023, 55 days after receiving the submission on November 1, 2023.
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 | K233515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2023 |
| Decision Date | December 26, 2023 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| 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. |