Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)— 510(k) K252226
Substantially EquivalentNuwellis, Inc.
FDA 510(k) clearance K252226 for Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102), Substantially Equivalent on 2025-08-13. Applicant: Nuwellis, Inc..
Clearance details
- Applicant
- Nuwellis, Inc.
- Product code
- Code NQJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Eden Prairie, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.