EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01— 510(k) K070320

Substantially Equivalent

Edwards Lifesciences Services GmbH

FDA 510(k) clearance K070320 for EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01, Substantially Equivalent on 2007-06-07. Applicant: Edwards Lifesciences Services GmbH.

Clearance details

Applicant: Edwards Lifesciences Services GmbH
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2007-02-02
Decision date: 2007-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevenage, GB

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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.