MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6— 510(k) K092177

Substantially Equivalent

Invatec S.P.A.

FDA 510(k) clearance K092177 for MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6, Substantially Equivalent on 2009-10-15. Applicant: Invatec S.P.A..

Clearance details

Applicant: Invatec S.P.A.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2009-07-21
Decision date: 2009-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

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.