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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2020-03-18 under 510(k) 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. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K200198.

When did WIRION receive FDA 510(k) clearance?

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

Who is the listed applicant for WIRION?

The FDA 510(k) record lists Cardiovascular Systems, Inc. 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.

Other records listing Cardiovascular Systems, Inc. as applicant

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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.K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott VascularK180023WIRIONGardia 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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