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FDA 510(k)

Aristotle Mini Guidewire

K-Number: K260223 · 2026-08-06

ApplicantScientia Vascular, Inc.
Decision Date2026-08-06
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aristotle Mini Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, Inc.. It received FDA 510(k) clearance on 2026-08-06 under 510(k) number K260223. 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 Mini Guidewire?

Aristotle Mini Guidewire is a medical device that received FDA 510(k) clearance on 2026-08-06. The listed applicant is Scientia Vascular, Inc.. The 510(k) number is K260223.

When did Aristotle Mini Guidewire receive FDA 510(k) clearance?

Aristotle Mini Guidewire received FDA 510(k) clearance on 2026-08-06, under 510(k) number K260223.

Who is the listed applicant for Aristotle Mini Guidewire?

The FDA 510(k) record lists Scientia Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aristotle Mini Guidewire?

The FDA product code for Aristotle Mini Guidewire is MOF.

Other records listing Scientia Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireK243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus GuidewireK242301Socrates 38 CatheterK223913Socrates Aspiration SystemK223560Plato 17 Microcatheter

View all 17 devices →

Related Devices (Code: MOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech LimitedK260537Willow 24 GuidewireArbor Endovascular, LLCK252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.K260130Willow 18 GuidewireArbor Endovascular, LLC

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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