Schneider Magnum Peripheral Recanal Guidewire

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

510(k) Number

K912156 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Schneider Intl., Ltd. →

• What is the primary clinical purpose of the Schneider Magnum Peripheral Recanal Guidewire, and how does it differ from standard guidewires?

  The Schneider Magnum Peripheral Recanal Guidewire is specifically designed for peripheral vascular recanalization, meaning it is used to open occluded or narrowed arteries in the legs, arms, or other peripheral blood vessels. Unlike standard guidewires, which may be used for general vessel access or support, this device is engineered to facilitate the restoration of blood flow through severely obstructed vessels, making it ideal for cases involving chronic total occlusions or severe stenosis. Its specialized design helps navigate and penetrate hardened plaque or blockages.

• Is the Schneider Magnum Peripheral Recanal Guidewire intended for reuse, or is it meant to be used only once?

  The device is explicitly labeled as single-use only. This means it should not be reused after a single procedure to ensure patient safety and maintain sterility. The regulatory submission does not indicate any reprocessing or sterilization protocols, reinforcing that each guidewire is intended for one-time use in a recanalization procedure.

• How is the Schneider Magnum Peripheral Recanal Guidewire supplied, and what should clinicians consider when handling it?

  The guidewire is supplied in a non-sterile state, which means it must be sterilized by the clinical facility prior to use. Clinicians should follow their institution’s established sterilization protocols (e.g., ethylene oxide, autoclave, or gamma irradiation) to ensure safety before insertion. Additionally, since it is single-use, proper disposal after use is critical to prevent contamination or reuse.

• What regulatory pathway was followed for FDA clearance of this guidewire, and what does that mean for clinicians?

  The Schneider Magnum Peripheral Recanal Guidewire received FDA 510(k) clearance under the Traditional review pathway, determined to be substantially equivalent to a legally marketed predicate device. This means the FDA evaluated it against an existing guidewire and confirmed it meets safety and effectiveness standards for peripheral vascular recanalization. Clinicians can rely on this clearance as evidence of the device’s regulatory compliance, though they should always follow their facility’s protocols for use and sterilization.