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Wirion

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200198

by Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K200198 FDA 510(k)
FDA Product Code
NTE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wirion is a temporary carotid catheter designed for embolic capture. It functions as an embolic protection system to assist in interventional procedures.

This device is authorized under FDA 510(k) clearance K200198. It is classified as a class 2 medical device under regulation number 870.1250.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cardiovascular Systems, Inc. Announces First Uses of WIRION® Embolic ..., Cardiovascular Systems acquires Gardia Medical's Wirion embolic ..., Cardiovascular Systems Acquires WIRION Embolic Protection System from ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiovascular Systems, Inc.

Sources (1)

  • FDA 510(k) K200198 24 fields · synced Sep 25, 2026