Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list CHF Solutions with 13 510(k) clearances. The most recent is a 510(k) clearance dated Feb 24, 2020: Aquadex FlexFlow System 2.0.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 24, 2020 | Aquadex FlexFlow System 2.0K192756 · KDI | 510(k) clearances |
| Sep 7, 2007 | AQUADEX FLEXFLOW SYSTEMK071854 · KDI | 510(k) clearances |
| Apr 27, 2007 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEMK070512 · KDI | 510(k) clearances |
| Dec 13, 2006 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEMK062922 · KDI | 510(k) clearances |
| Feb 2, 2006 | AQUADEX FLEXFLOW SYSTEMK060008 · KDI | 510(k) clearances |
| Nov 9, 2005 | AQUADEX SYSTEMK050609 · KDI | 510(k) clearances |
| Sep 10, 2004 | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)K041791 · NQJ | 510(k) clearances |
| Apr 27, 2004 | AQUADEX SYSTEM 100, MODEL A1100K040489 · KDI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
