SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET— 510(k) K132429

Substantially Equivalent

Terumobct, Inc.

FDA 510(k) clearance K132429 for SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET, Substantially Equivalent on 2013-12-06. Applicant: Terumobct, Inc..

Clearance details

Applicant: Terumobct, Inc.
Product code: Code LKN
Advisory panel: Unknown
Date received: 2013-08-05
Decision date: 2013-12-06
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.