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FDA 510(k)

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

K-Number: K191173 · 2019-07-25

ApplicantAbbott Vascular
Decision Date2019-07-25
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is a medical device manufactured by Abbott Vascular. It received FDA 510(k) clearance on 2019-07-25 under approval number K191173. 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 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires?

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Abbott Vascular. The 510(k) number is K191173.

When was Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires approved by the FDA?

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires received FDA 510(k) clearance on 2019-07-25, under approval number K191173.

What company makes Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires?

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is manufactured by Abbott Vascular.

What is the FDA product code for Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires?

The FDA product code for Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires is NTE.

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Related Devices (Code: NTE)

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Official Source

View on FDA Database →

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

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