CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE— 510(k) K120298

Substantially Equivalent

St. Jude Medical, Cardiac Rhythm Management Divisi

FDA 510(k) clearance K120298 for CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE, Substantially Equivalent on 2012-05-08. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi.

Clearance details

Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2012-01-31
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, 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.