The following data is part of a premarket notification filed by Chf Solutions, Inc. with the FDA for Aquadex Flexflow System 2.0.
| Device ID | K192756 |
| 510k Number | K192756 |
| Device Name: | Aquadex FlexFlow System 2.0 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | CHF Solutions, Inc. 12988 Valley View Road Eden Prairie, MN 55344 |
| Contact | Dawn Li |
| Correspondent | Dawn Li CHF Solutions, Inc. 12988 Valley View Road Eden Prairie, MN 55344 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853072007128 | K192756 | 000 |
| 10853072007111 | K192756 | 000 |
| 10853072007104 | K192756 | 000 |
| 30853072007306 | K192756 | 000 |