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

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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2021-03-03 under 510(k) 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. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K210282.

When did WIRION Embolic Protection System receive FDA 510(k) clearance?

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

Who is the listed applicant for WIRION Embolic Protection System?

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 Embolic Protection System?

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

Other records listing Cardiovascular Systems, Inc. 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 P130005CATHETER, CORONARY, ATHERECTOMYK220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy SystemK212725ViperCross Support CathetersK210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy systemK211240ViperCross Support CathetersK211251ViperCath XC Peripheral Exchange Catheter

View all 14 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 CorporationK200198WIRIONCardiovascular 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.

↑