ANCHORWIRE GUIDEWIRE— 510(k) K111288

Substantially Equivalent

Lake Region Medical

FDA 510(k) clearance K111288 for ANCHORWIRE GUIDEWIRE, Substantially Equivalent on 2011-08-02. Applicant: Lake Region Medical.

Clearance details

Applicant: Lake Region Medical
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2011-05-06
Decision date: 2011-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, 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.