Heavy Double Flexible Tipped Wire Guide— 510(k) K150802

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K150802 for Heavy Double Flexible Tipped Wire Guide, Substantially Equivalent on 2015-05-28. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2015-03-26
Decision date: 2015-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.