K123039

Substantially Equivalent

CDI BLOOD PARAMETER MONITORING SYSTEM 500

Applicant: Terumo Cardiovascular Systems Corp.
Product code: DRY
Advisory panel: Cardiovascular
Date received: 2012-09-28
Decision date: 2012-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.