STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078— 510(k) K090163

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K090163 for STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078, Substantially Equivalent on 2009-04-01. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2009-01-22
Decision date: 2009-04-01
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.