MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151— 510(k) K080924

Substantially Equivalent

St. Jude Medical, Cardiac Rhythm Management Divisi

FDA 510(k) clearance K080924 for MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151, Substantially Equivalent on 2008-04-30. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi.

Clearance details

Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2008-04-02
Decision date: 2008-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.