AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE— 510(k) K111702

Substantially Equivalent

Fenwal, Inc.

FDA 510(k) clearance K111702 for AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE, Substantially Equivalent on 2012-03-22. Applicant: Fenwal, Inc..

Clearance details

Applicant: Fenwal, Inc.
Product code: Code LKN
Advisory panel: Unknown
Date received: 2011-06-17
Decision date: 2012-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, US

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Adverse events under product code LKN

product code LKN

Death: 50
Injury: 314
Total: 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.