K153601

Substantially Equivalent

Spectra Optia Apheresis System

Applicant: Terumobct, Inc.
Product code: LKN
Advisory panel: Unknown
Date received: 2015-12-16
Decision date: 2016-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Lakewood, CO, US

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.