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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K260223

510(k) cleared

Aristotle Mini Guidewire

Scientia Vascular, Inc. · Aug 6, 2026 · K260223

FDA cleared the Aristotle Mini Guidewire from Scientia Vascular, Inc. on Aug 6, 2026 under K260223, 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 Jan 26, 2026. The decision came 192 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Scientia Vascular, Inc. has 2 other decisions in the tracker over the last 12 months: 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 K260223?

K260223 is the FDA 510(k) for Aristotle Mini Guidewire, submitted by Scientia Vascular, Inc.. FDA's decision date was Aug 6, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the Aristotle Mini Guidewire?

Scientia Vascular, Inc., based in West Valley City, UT, is the applicant of record for K260223.

How long did the K260223 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Aug 6, 2026, 192 days later.

← All decisions in August 2026

Sources