510(k) K031689
K031689 is an FDA 510(k) premarket notification submitted by Chf Solutions, Inc. for the device "DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)". The FDA issued a decision of Substantially Equivalent on December 23, 2003. 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. Chf Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2003
- Date Received
- June 2, 2003
- 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.