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FDA 510(k)

Aristotle 18 Guidewire; Aristotle 24 Guidewire

K-Number: K231954 · 2023-08-01

ApplicantScientia Vascular, Inc.
Decision Date2023-08-01
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aristotle 18 Guidewire; Aristotle 24 Guidewire is a medical device manufactured by Scientia Vascular, Inc.. It received FDA 510(k) clearance on 2023-08-01 under approval number K231954. 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 18 Guidewire; Aristotle 24 Guidewire?

Aristotle 18 Guidewire; Aristotle 24 Guidewire is a medical device that received FDA 510(k) clearance on 2023-08-01. It is manufactured by Scientia Vascular, Inc.. The 510(k) number is K231954.

When was Aristotle 18 Guidewire; Aristotle 24 Guidewire approved by the FDA?

Aristotle 18 Guidewire; Aristotle 24 Guidewire received FDA 510(k) clearance on 2023-08-01, under approval number K231954.

What company makes Aristotle 18 Guidewire; Aristotle 24 Guidewire?

Aristotle 18 Guidewire; Aristotle 24 Guidewire is manufactured by Scientia Vascular, Inc..

What is the FDA product code for Aristotle 18 Guidewire; Aristotle 24 Guidewire?

The FDA product code for Aristotle 18 Guidewire; Aristotle 24 Guidewire is MOF.

Other Devices by Scientia Vascular, Inc.

K223913Socrates Aspiration System K223560Plato 17 Microcatheter K222437Aristotle Colossus 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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