
Invatec S.P.A.
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MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 is an FDA 510(k)-cleared medical device (K092177) manufactured by Invatec S.P.A.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2009. Regulation: 8.