FDA 510(k)

WIRION

K-Number: K180023 · 2018-03-21

Decision Date2018-03-21

Product CodeNTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WIRION is the device name listed in this FDA 510(k) record. The listed applicant is Gardia Medical , Ltd.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K180023. 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 WIRION?

WIRION is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Gardia Medical , Ltd.. The 510(k) number is K180023.

When did WIRION receive FDA 510(k) clearance?

WIRION received FDA 510(k) clearance on 2018-03-21, under 510(k) number K180023.

Who is the listed applicant for WIRION?

The FDA 510(k) record lists Gardia Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIRION?

The FDA product code for WIRION is NTE.

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 Medical K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation K210282WIRION 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.