MULTI LEAD TRIAL CABLE— 510(k) K130545

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K130545 for MULTI LEAD TRIAL CABLE, Substantially Equivalent on 2013-06-18. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code GZB
Advisory panel: Neurology
Date received: 2013-03-01
Decision date: 2013-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.