Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
FDA 510(k) clearance K252226 · decided 2025-08-13
Clearance details
- K-number
- K252226
- Device name
- Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- Applicant
- Nuwellis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-16
- Decision date
- 2025-08-13
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NQJ
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (K233515) | Nuwellis, Inc. | 2023-12-26 |
| 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K041791) | Chf Solutions, Inc. | 2004-09-10 |
| DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K031689) | Chf Solutions, Inc. | 2003-12-23 |
Recalls involving this device
No recalls on record reference this clearance.