K151368

Substantially Equivalent

Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter

Applicant: Terumo Bct
Product code: LKN
Advisory panel: Unknown
Date received: 2015-05-21
Decision date: 2015-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
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.