Aquadex FlexFlow System 2.0— 510(k) K192756

Substantially Equivalent

Chf Solutions, Inc.

FDA 510(k) clearance K192756 for Aquadex FlexFlow System 2.0, Substantially Equivalent on 2020-02-24. Applicant: Chf Solutions, Inc..

Clearance details

Applicant: Chf Solutions, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-30
Decision date: 2020-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.