510(k) K233515
K233515 is an FDA 510(k) premarket notification submitted by Nuwellis, Inc. for the device "Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)". The FDA issued a decision of Substantially Equivalent on December 26, 2023. 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
- December 26, 2023
- Date Received
- November 1, 2023
- Clearance Type
- Traditional
- 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.