# Nuwellis, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 2 (2023–2025): 2 510(k) clearances
- Product codes: NQJ (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Chf Solutions, Inc.: 2 (https://510kreport.com/company/chf-solutions)

## Its most-cited devices
- K233515: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (2023), cited by 1

## Recent decisions
- K252226: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (Aug 13, 2025)
- K233515: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (Dec 26, 2023)

Source page: https://510kreport.com/company/nuwellis