Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WIRION

K-Number: K200198 · 2020-03-18

ApplicantCardiovascular Systems, Inc.
Decision Date2020-03-18
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WIRION is a medical device manufactured by Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2020-03-18 under approval number K200198. 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 2020-03-18. It is manufactured by Cardiovascular Systems, Inc.. The 510(k) number is K200198.

When was WIRION approved by the FDA?

WIRION received FDA 510(k) clearance on 2020-03-18, under approval number K200198.

What company makes WIRION?

WIRION is manufactured by Cardiovascular Systems, Inc..

What is the FDA product code for WIRION?

The FDA product code for WIRION is NTE.

Other Devices by Cardiovascular Systems, Inc.

K170792Diamondback 360 Peripheral Orbital Atherectomy System K183000ViperCath XC Peripheral Exchange Catheter K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

View all 14 devices →

Related Devices (Code: NTE)

K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. K180023WIRIONGardia Medical , Ltd. K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular K210282WIRION Embolic Protection SystemCardiovascular 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.

↑