K252226
- 510(k) number
- K252226
- Device name
- Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- Applicant
- Nuwellis, Inc. MN · US
- Product code
- NQJ — Catheter, Hemodialysis, Non-Implanted, Ultrafiltrati
- Decision date
- 2025-08-13
- Date received
- 2025-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252226.pdf
Official FDA record: K252226
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.