DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Invatec S.P.A.
Product code
Code NTE
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bethlehem, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NTE

product code NTE
Death
28
Injury
1,348
Malfunction
771
Total
2,147

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K092177

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092177.

Data sourced from openFDA. This site is unofficial and independent of the FDA.