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FDA 510(k)

MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6

K-Number: K092177 · 2009-10-15

ApplicantInvatec S.P.A.
Decision Date2009-10-15
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 is the device name listed in this FDA 510(k) record. The listed applicant is Invatec S.P.A.. It received FDA 510(k) clearance on 2009-10-15 under 510(k) number K092177. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6?

MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 is a medical device that received FDA 510(k) clearance on 2009-10-15. The listed applicant is Invatec S.P.A.. The 510(k) number is K092177.

When did MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 receive FDA 510(k) clearance?

MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 received FDA 510(k) clearance on 2009-10-15, under 510(k) number K092177.

Who is the listed applicant for MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6?

The FDA 510(k) record lists Invatec S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6?

The FDA product code for MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 is NTE.

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Other records listing Invatec S.P.A. as applicant

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Related Devices (Code: NTE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road MedicalK220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis CorporationK210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.K200198WIRIONCardiovascular Systems, Inc.K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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