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

Name: FDA 510(k) clearance K090163
Creator: U.S. Food and Drug Administration
Published: 2009-04-01

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. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code DRB
Device class: Class 2
Regulation: 21 CFR 870.1380
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 ↗

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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.