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FDA 510(k)

WIRION Embolic Protection System

K-Number: K210282 · 2021-03-03

ApplicantCardiovascular Systems, Inc.
Decision Date2021-03-03
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WIRION Embolic Protection System is a medical device manufactured by Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2021-03-03 under approval number K210282. 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 Embolic Protection System?

WIRION Embolic Protection System is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by Cardiovascular Systems, Inc.. The 510(k) number is K210282.

When was WIRION Embolic Protection System approved by the FDA?

WIRION Embolic Protection System received FDA 510(k) clearance on 2021-03-03, under approval number K210282.

What company makes WIRION Embolic Protection System?

WIRION Embolic Protection System is manufactured by Cardiovascular Systems, Inc..

What is the FDA product code for WIRION Embolic Protection System?

The FDA product code for WIRION Embolic Protection System is NTE.

Related Clinical Trials

NCT06027788 CTSN Embolic Protection Trial RECRUITING NCT07541404 MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma NOT_YET_RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING NCT06735833 MMA Embolization for Refractory Chronic Migraine RECRUITING NCT07576790 Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT) NOT_YET_RECRUITING NCT07528144 Exoskeleton vs. Standard Lead Apron in EVAR Procedures RECRUITING

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Related Devices (Code: NTE)

K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. K180023WIRIONGardia Medical , Ltd. K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular K200198WIRIONCardiovascular Systems, Inc. K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.

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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