FLEXMEDICS GUIDEWIRE— 510(k) K893626

Substantially Equivalent

Flexmedics

FDA 510(k) clearance K893626 for FLEXMEDICS GUIDEWIRE, Substantially Equivalent on 1989-09-26. Applicant: Flexmedics.

Clearance details

Applicant: Flexmedics
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1989-05-11
Decision date: 1989-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findley, 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.