Nuwellis, Inc.
FDA 510(k) & PMA Approved Devices — 2 products
Total Devices2
Categories1
Latest FDA decision2025-08-13
SEC Filings: 1 filings on record. Latest: 8-K (2026-08-26). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | NQJ | 2025-08-13 | View |
| 510(k) | K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | NQJ | 2023-12-26 | View |
No matching devices.