The following data is part of a premarket notification filed by Chf Solutions, Inc. with the FDA for Aquadex System.
| Device ID | K050609 |
| 510k Number | K050609 |
| Device Name: | AQUADEX SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | CHF SOLUTIONS, INC. 7601 NORTHLAND DR. STE. 170 Brooklyn Park, MN 55428 |
| Contact | Chris Scavotto |
| Correspondent | Chris Scavotto CHF SOLUTIONS, INC. 7601 NORTHLAND DR. STE. 170 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 | 2005-03-10 |
| Decision Date | 2005-11-09 |
| Summary: | summary |