TLINK DATA MANAGEMENT SYSTEM (DMS)— 510(k) K113214

Substantially Equivalent

Terumo Cardiovascular Systems Corp.

FDA 510(k) clearance K113214 for TLINK DATA MANAGEMENT SYSTEM (DMS), Substantially Equivalent on 2012-02-07. Applicant: Terumo Cardiovascular Systems Corp..

Clearance details

Applicant: Terumo Cardiovascular Systems Corp.
Product code: 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

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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.