Guidewires

Aristotle

by Scientia Vascular LLC

A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

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Aristotle models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
14-200-001β€” MR UnsafeAvailable
14-200-002β€” MR UnsafeAvailable
14-200-003Guidewire Length 200 cm; Guidewire Diameter 0.014 in MR UnsafeAvailable
14-200-004Guidewire Length 200 cm; Guidewire Diameter 0.014 in MR UnsafeAvailable
14-300-001β€” MR UnsafeAvailable
14-300-002β€” MR UnsafeAvailable
14-300-003Guidewire Diameter 0.014 in; Guidewire Length 300 cm MR UnsafeAvailable
14-300-004Guidewire Diameter 0.014 in; Guidewire Length 300 cm MR UnsafeAvailable
18-200-001β€” MR UnsafeAvailable
18-200-002β€” MR UnsafeAvailable
18-200-003β€” MR UnsafeAvailable
24-200-001β€” MR UnsafeAvailable
24-200-002β€” MR UnsafeAvailable
24-200-003β€” MR UnsafeAvailable
01862β€” MR UnsafeAvailable
01863β€” MR UnsafeAvailable
01864β€” MR UnsafeAvailable
01954β€” MR UnsafeAvailable
01955β€” MR UnsafeAvailable
01956β€” MR UnsafeAvailable
ACL-200-002β€” MR UnsafeAvailable
ACL-300-002β€” MR UnsafeAvailable

FDA clearances

  • 510(k) K222437 January 2023
  • 510(k) K201760 July 2020
  • 510(k) K192783 October 2019
  • 510(k) K183608 March 2019
  • 510(k) K173235 January 2018

Procedures that use guidewires

Frequently asked questions

What is Aristotle used for?

A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Who makes Aristotle?

Aristotle is made by Scientia Vascular LLC. It is listed under guidewires in our device library.

What sizes does Aristotle come in?

Sizes listed for Aristotle: Guidewire Diameter: 0.01 in; Guidewire Length: 200–300 cm. Confirm availability with the manufacturer's instructions for use.

Is Aristotle MRI safe?

The FDA device database lists Aristotle as MR Unsafe. Always follow the specific MRI conditions in the labeling.

Is Aristotle FDA cleared?

Aristotle is covered by FDA submissions K192783, K173235, K183608, K201760, K222437.

How do I contact a Scientia Vascular LLC sales representative?

Scientia Vascular LLC has not listed representatives on LA Vascular yet. Visit the Scientia Vascular LLC company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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