510(k) K252226
K252226 is an FDA 510(k) premarket notification submitted by Nuwellis, Inc. for the device "Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)". The FDA issued a decision of Substantially Equivalent on August 13, 2025. The device falls under product code NQJ (Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use), a Class II device regulated under 21 CFR 876.5540. Nuwellis, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2025
- Date Received
- July 16, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.