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

Name: FDA 510(k) clearance K063293
Creator: U.S. Food and Drug Administration
Published: 2007-03-23

Substantially Equivalent

Edwards Lifesciences Services GmbH

FDA 510(k) clearance K063293 for EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE, Substantially Equivalent on 2007-03-23. Applicant: Edwards Lifesciences Services GmbH. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences Services GmbH
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2006-11-01
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevenage, GB

Download summary PDF View on FDA.gov ↗

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K213992 — CombiSet Hemodialysis Blood Tubing Set2023-05-31

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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.