Solitaire FR Revascularization Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K113455 ↗

FDA Product Code

NRY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cadence

  Class I

  CE/MDR

• 1 mL syringe

  Class I

  CE/MDR

• Onyx SCIFA

  Class I

  CE/MDR

• Riptide Aspiration System

  Class II

  FDA 510(k) K201689 Active Cleared 21 Jul 2020

• Solitaire 2 Revascularization Device

  Class II

  FDA 510(k) K162539 Active Cleared 10 Nov 2016

• Axium Detachable Coil; Axium Prime Detachable Coil

  Class II

  FDA 510(k) K233420 Active Cleared 7 Nov 2023

See all devices from Micro Therapeutics, Inc. d/b/a ev3 Neurovascular →

• What is the Solitaire FR Revascularization Device used for?

  The Solitaire FR Revascularization Device is a catheter-based thrombus retriever designed for use in the cardiovascular system. It is intended to be delivered through a micro catheter, deployed across a clot in an occluded intracranial vessel, and removed along with the clot to enable revascularization.

• Is the Solitaire FR Revascularization Device sterile and single-use?

  Yes, the device is supplied as a single-use, sterile product. This means it is intended for one patient only and must not be reprocessed or reused, ensuring patient safety and reducing infection risk in neurovascular procedures.

• What regulatory pathway was used for the Solitaire FR Revascularization Device?

  The device received FDA 510(k) clearance under submission K113455 on March 2, 2012. It was found substantially equivalent to a predicate device and is classified as a Class II medical device under regulation 870.1250 with product code NRY.