MEDTRONIC EXPORT XT CATHETER— 510(k) K061958

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K061958 for MEDTRONIC EXPORT XT CATHETER, Substantially Equivalent on 2006-09-05. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2006-07-11
Decision date: 2006-09-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

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Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.