Medtronic Confida Brecker Guidewire— 510(k) K150465

Substantially Equivalent

Medtronic Core Valve, LLC

FDA 510(k) clearance K150465 for Medtronic Confida Brecker Guidewire, Substantially Equivalent on 2015-08-03. Applicant: Medtronic Core Valve, LLC.

Clearance details

Applicant: Medtronic Core Valve, LLC
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2015-02-23
Decision date: 2015-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.