FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
K Number: K252226
·
Decision Aug 13, 2025
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
2
Review Days
28
Basic Information
- Device Name
- Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- K Number
- K252226
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuwellis, Inc.
- Date Received
- July 16, 2025
- Decision Date
- August 13, 2025
- Product Code
- NQJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NQJ | Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQJ), ordered by most recent decision date.
Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Nuwellis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Dec 26, 2023 | Substantially Equivalent |