K113214

Substantially Equivalent

TLINK DATA MANAGEMENT SYSTEM (DMS)

Applicant: Terumo Cardiovascular Systems Corp.
Product code: DXJ
Advisory panel: Cardiovascular
Date received: 2011-10-31
Decision date: 2012-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.