Aristotle 18 Guidewire; Aristotle 24 Guidewire

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K231954Ref A18-200-002Model 00918

by Scientia Vascular, Inc.

Identity

Trade Name: Aristotle 18 Guidewire EUDAMED
Aristotle FDA UDI
Generic Name: Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name: Aristotle 18 Guidewire EUDAMED
Guidewire-Standard FDA UDI
Model / Reference: 00918 EUDAMED
A18-200-002 EUDAMED
18-200-002 FDA UDI
Description: Guidewire-Standard FDA UDI

Identifiers

Catalog Number: A18-200-002 FDA UDI
Primary DI / UDI-DI: 00818075010103 EUDAMEDFDA UDI
Basic UDI-DI: B-00818075010103 EUDAMED
510(k) Number: K231954 FDA 510(k)
K183608 FDA UDI
FDA Product Code: MOF FDA 510(k)FDA UDI
DQX FDA UDI
EMDN Code: C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
GMDN Term: Cardiac/peripheral vascular guidewire, single-use FDA UDI
Models / Variants: Aristotle 18 Guidewire FDA 510(k)FDA UDIEUDAMED
Aristotle 24 Guidewire FDA 510(k)FDA UDIEUDAMED

Classification

Device Class: Class III EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 870.1330 FDA 510(k)
Regulation Number: 870.1330 FDA 510(k)FDA UDI
Market of Registration: Germany EUDAMED
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

The Aristotle 18 Guidewire and Aristotle 24 Guidewire are steerable guidewires designed for neurovascular and peripheral vascular access. These devices feature a shapeable tip and varying stiffness profiles to assist in navigating tortuous vasculature, with a hydrophilic polymer coating on the distal portion and a PTFE coating on the proximal portion to minimize friction during manipulation.

Supplied as single-use devices, the Aristotle guidewires are intended for use in interventional procedures within neuro and peripheral vasculatures to introduce and position catheters. They are classified as Class II medical devices under the FDA and comply with the Medical Device Directive (MDD). The devices are authorized via FDA 510(k) clearance (K231954) and are manufactured by Scientia Vascular, Inc.

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: PDF Aristotle 18 Guidewire - Medtronic, Aristotle™ 24 guidewire - Medtronic, PDF Aristotle 18 Guidewires, The Aristotle 18 and 24 microwires in neuroIntervention: Early ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K231954	Class II	Active

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Manufacturer

Manufacturer: Scientia Vascular, Inc.

Sources (3)

FDA 510(k) K231954 24 fields · synced Sep 18, 2026
FDA UDI 7c8d4593-2c39-4ffd-b998-b66ab84f718f 37 fields · synced May 29, 2026
EUDAMED 3cac97a2-2f64-453c-b877-f8c3ee22aefb 61 fields · synced Jul 18, 2026