CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector— 510(k) K142254

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K142254 for CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector, Substantially Equivalent on 2014-11-13. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2014-08-14
Decision date: 2014-11-13
Decision: Substantially Equivalent
Clearance type: Special
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.