Lunderquist Extra Stiff Wire Guide— 510(k) K220137

Substantially Equivalent

William Cook Europe Aps

FDA 510(k) clearance K220137 for Lunderquist Extra Stiff Wire Guide, Substantially Equivalent on 2022-02-17. Applicant: William Cook Europe Aps.

Clearance details

Applicant: William Cook Europe Aps
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2022-01-18
Decision date: 2022-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Bjaeverskov, DK

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.