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Aristotle Colossus Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222437

by Scientia Vascular, Inc.

Identifiers

510(k) Number
K222437 FDA 510(k)
FDA Product Code
MOF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Aristotle Colossus Guidewire is a steerable guidewire designed for neurovascular and peripheral vascular access. It features a shapeable distal tip and a 0.035-inch diameter, enabling precise navigation through complex vascular pathways to facilitate catheter and device placement.

This device is supplied as a single-use, non-sterile instrument intended for use in interventional cardiology and neurovascular procedures. It includes a hydrophilic polymer coating on the distal portion and a PTFE coating on the proximal portion to minimize friction during manipulation. The guidewire is classified under FDA regulation number 870.1330 and holds a 510(k) clearance (K222437) for traditional review in the cardiovascular category.

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 Colossus Guidewire - Medtronic, Aristotle™ Colossus™ guidewire - Medtronic, PDF Aristotle Colossus Guidewire, Aristotle Colossus Guidewire (K222437) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Scientia Vascular, Inc.

Sources (1)

  • FDA 510(k) K222437 24 fields · synced Sep 19, 2026