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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 / April 2026 / K253579

510(k) cleared

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

Scientia Vascular, Inc. · Apr 29, 2026 · K253579

FDA cleared the Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire from Scientia Vascular, Inc. on Apr 29, 2026 under K253579, 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 Nov 17, 2025. The decision came 163 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: K260223 (Aristotle Mini Guidewire), K260002 (Socrates Aspiration System (Socrates 70 Aspiration Catheter)).

Questions & Answers

What did FDA clear under K253579?

K253579 is the FDA 510(k) for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire, submitted by Scientia Vascular, Inc.. FDA's decision date was Apr 29, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire?

Scientia Vascular, Inc., based in West Valley City, UT, is the applicant of record for K253579.

How long did the K253579 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 29, 2026, 163 days later.

← All decisions in April 2026

Sources