510(k) K010906— MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254

Substantially Equivalent

Medtronic Vascular

Clearance details

Applicant: Medtronic Vascular
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2001-03-26
Decision date: 2001-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreview, MN, US

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.