The following data is part of a premarket notification filed by Chf Solutions, Inc. with the FDA for System 100-uf 500 Circuit With In-line Needleless Access Port.
| Device ID | K024124 |
| 510k Number | K024124 |
| Device Name: | SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| 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 | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-03-14 |
| Summary: | summary |