MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE— 510(k) K102818

Substantially Equivalent

Micrus Endovascular Corporation

FDA 510(k) clearance K102818 for MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE, Substantially Equivalent on 2010-12-03. Applicant: Micrus Endovascular Corporation.

Clearance details

Applicant: Micrus Endovascular Corporation
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2010-09-28
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, 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.