510(k) K063293— EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE

Substantially Equivalent

Edwards Lifesciences Services GmbH

Clearance details

Applicant: Edwards Lifesciences Services GmbH
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2006-11-01
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevenage, GB

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.