MODIFICATION TO: EXPORT CATHETER— 510(k) K050139

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K050139 for MODIFICATION TO: EXPORT CATHETER, Substantially Equivalent on 2005-03-22. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2005-01-21
Decision date: 2005-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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.