STYLET KIT, MODELS 6254,6282,6293— 510(k) K003535

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K003535 for STYLET KIT, MODELS 6254,6282,6293, Substantially Equivalent on 2001-02-08. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2000-11-16
Decision date: 2001-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreview, MN, 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.