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The Tracker / September 2026 / K254181

510(k) cleared

Aristotle 65 Macrowire

Scientia Vascular · Sep 16, 2026 · K254181

FDA cleared the Aristotle 65 Macrowire from Scientia Vascular on Sep 16, 2026 under K254181, a traditional 510(k). The device falls under product code MOF, Guide, Wire, Catheter, Neurovasculature, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 23, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Scientia Vascular has 3 other decisions in the tracker over the last 12 months: K260223 (Aristotle Mini Guidewire), K260002 (Socrates Aspiration System (Socrates 70 Aspiration Catheter)), K253579 (Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire).

Questions & Answers

What did FDA clear under K254181?

K254181 is the FDA 510(k) for Aristotle 65 Macrowire, submitted by Scientia Vascular. FDA's decision date was Sep 16, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the Aristotle 65 Macrowire?

Scientia Vascular, based in West Valley City, UT, is the applicant of record for K254181.

How long did the K254181 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Sep 16, 2026, 267 days later.

← All decisions in September 2026

Sources