FDA Product Code
FDA Product Code NQJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | 2025-08-13 | Special | PDF ↗ |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | 2023-12-26 | Traditional | PDF ↗ |
| K041791 | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2004-09-10 | Traditional | PDF ↗ |
| K031689 | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2003-12-23 | Traditional | PDF ↗ |
Product code NQJ · Class II · Gastroenterology, Urology. Data: openFDA.