Aquadex FlexFlow System 2.0
FDA 510(k) clearance K192756 · decided 2020-02-24
Clearance details
- K-number
- K192756
- Device name
- Aquadex FlexFlow System 2.0
- Applicant
- Chf Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2020-02-24
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood recall (Z-0831-2025) | Nuwellis Inc | 2025-01-16 |