The following data is part of a premarket notification filed by Chf Solutions, Inc. with the FDA for Dual Lumen Extended Length Catheter (delc).
| Device ID | K031689 |
| 510k Number | K031689 |
| Device Name: | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) |
| Classification | Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use |
| Applicant | CHF SOLUTIONS, INC. SUITE 170-7601 NORTHLAND DR. Brooklyn Park, MN 55428 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson CHF SOLUTIONS, INC. SUITE 170-7601 NORTHLAND DR. Brooklyn Park, MN 55428 |
| Product Code | NQJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2003-12-23 |
| Summary: | summary |