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FDA 510(k)

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

K-Number: K253579 · 2026-04-29

ApplicantScientia Vascular, Inc.
Decision Date2026-04-29
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire is a medical device manufactured by Scientia Vascular, Inc.. It received FDA 510(k) clearance on 2026-04-29 under approval number K253579. 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 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Scientia Vascular, Inc.. The 510(k) number is K253579.

When was Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire approved by the FDA?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire received FDA 510(k) clearance on 2026-04-29, under approval number K253579.

What company makes Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire is manufactured by Scientia Vascular, Inc..

What is the FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire?

The FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire is MOF.

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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