K233515
- 510(k) number
- K233515
- Device name
- Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (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
- 2023-12-26
- Date received
- 2023-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233515.pdf
Official FDA record: K233515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.