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FDA 510(k)

Aristotle Colossus Guidewire

K-Number: K222437 · 2023-01-26

ApplicantScientia Vascular, Inc.
Decision Date2023-01-26
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aristotle Colossus Guidewire is a medical device manufactured by Scientia Vascular, Inc.. It received FDA 510(k) clearance on 2023-01-26 under approval number K222437. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aristotle Colossus Guidewire?

Aristotle Colossus Guidewire is a medical device that received FDA 510(k) clearance on 2023-01-26. It is manufactured by Scientia Vascular, Inc.. The 510(k) number is K222437.

When was Aristotle Colossus Guidewire approved by the FDA?

Aristotle Colossus Guidewire received FDA 510(k) clearance on 2023-01-26, under approval number K222437.

What company makes Aristotle Colossus Guidewire?

Aristotle Colossus Guidewire is manufactured by Scientia Vascular, Inc..

What is the FDA product code for Aristotle Colossus Guidewire?

The FDA product code for Aristotle Colossus Guidewire is MOF.

Other Devices by Scientia Vascular, Inc.

K223913Socrates Aspiration System K223560Plato 17 Microcatheter K231954Aristotle 18 Guidewire; Aristotle 24 Guidewire K242301Socrates 38 Catheter K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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