EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00— 510(k) K090682

Substantially Equivalent

Edwards Lifesciences Services GmbH

FDA 510(k) clearance K090682 for EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00, Substantially Equivalent on 2009-11-19. Applicant: Edwards Lifesciences Services GmbH.

Clearance details

Applicant: Edwards Lifesciences Services GmbH
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2009-03-16
Decision date: 2009-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Welwyn Garden City, GB

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.