Spectra Optia Apheresis System— 510(k) K172590

Substantially Equivalent

Terumobct, Inc.

FDA 510(k) clearance K172590 for Spectra Optia Apheresis System, Substantially Equivalent on 2018-03-02. Applicant: Terumobct, Inc..

Clearance details

Applicant: Terumobct, Inc.
Product code: Code LKN
Advisory panel: Unknown
Date received: 2017-08-29
Decision date: 2018-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, 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.