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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2019-07-25 under 510(k) 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. The listed applicant is Abbott Vascular. The 510(k) number is K191173.

When did Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires receive FDA 510(k) clearance?

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

Who is the listed applicant for Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires?

The FDA 510(k) record lists Abbott Vascular as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Other records listing Abbott Vascular as applicant

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.

PMA P110019Coronary drug-eluting stentPMA P960043Device, hemostasis, vascularPMA P040038Stent, carotidPMA P110028STENT, ILIACPMA P110001STENT, RENALPMA P040012Stent, carotid

View all 21 devices →

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.K180023WIRIONGardia Medical , Ltd.

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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