MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES— 510(k) K041338

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K041338 for MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES, Substantially Equivalent on 2004-07-19. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code MWS
Advisory panel: Cardiovascular
Date received: 2004-05-20
Decision date: 2004-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Park, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWS

product code MWS

Death: 4
Total: 4

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.