K153143

Substantially Equivalent

Capiox Advance Hardshell Reservoir

Applicant: Terumo Cardiovascular Systems Corporation
Product code: DTN
Advisory panel: Cardiovascular
Date received: 2015-10-30
Decision date: 2015-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkton, MD, US

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.