COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS— 510(k) K982413

Substantially Equivalent

Gambro Healthcare

FDA 510(k) clearance K982413 for COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS, Substantially Equivalent on 1999-04-21. Applicant: Gambro Healthcare.

Clearance details

Applicant: Gambro Healthcare
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1998-07-13
Decision date: 1999-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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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.