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Solitaire X Revascularization Device

by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

510(k) K203358

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203358 Date1 Mar 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
POL
Device Class
Class II
Regulation
21 CFR Part 882.5600
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Solitaire X Revascularization Device is a neurovascular mechanical thrombectomy device designed for acute ischemic stroke treatment. Classified as a Class II device under FDA regulations, it is intended for the removal of thrombi from cerebral arteries to restore blood flow in patients experiencing acute ischemic stroke.

This device is supplied sterile and intended for single-use. It is deployed via a microcatheter and features an overlapping stent design for improved clot retention and vessel expansion during retrieval. The device is regulated under FDA 510(k) clearance (K203358) and is intended for use in neurology settings. Storage and handling must comply with sterile medical device protocols.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Solitaire X Revascularization Device primarily used for in clinical practice?

    The Solitaire X Revascularization Device is designed specifically for the removal of thrombi (blood clots) from cerebral arteries to restore blood flow in patients suffering from acute ischemic stroke. Its overlapping stent design helps retain clots securely while allowing vessel expansion during retrieval, making it a targeted solution for neurovascular emergencies.

  • How is the Solitaire X device supplied and what are its usage instructions regarding sterility?

    The Solitaire X Revascularization Device is supplied sterile and is intended for single-use only. This means it must be handled and stored according to sterile medical device protocols to ensure patient safety and device efficacy. Once deployed, it should not be reused.

  • Is the Solitaire X device compatible with specific microcatheters, or can it be used with any standard neurovascular catheter?

    The device is deployed via a microcatheter, but the exact compatibility depends on the catheter’s specifications. While the Solitaire X is designed for neurovascular use, clinicians should verify compatibility with their chosen microcatheter to ensure proper deployment and retrieval of thrombi. Manufacturer guidelines should be consulted for precise pairing.

  • What regulatory pathway does the Solitaire X follow, and where can I find additional details about its clearance?

    The Solitaire X Revascularization Device follows the FDA 510(k) clearance pathway, classified as a Class II device under FDA regulations. It received clearance under K203358 with a decision date of March 1, 2021. For further details, including the full regulatory submission, you may contact Micro Therapeutics, Inc. d/b/a ev3 Neurovascular at their Irvine, CA office.