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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 / July 2026 / K260002

510(k) cleared

Socrates Aspiration System (Socrates 70 Aspiration Catheter)

Scientia Vascular, Inc. · Jul 16, 2026 · K260002

FDA cleared the Socrates Aspiration System (Socrates 70 Aspiration Catheter) from Scientia Vascular, Inc. on Jul 16, 2026 under K260002, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 2, 2026. The decision came 195 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), K253579 (Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire).

Questions & Answers

What did FDA clear under K260002?

K260002 is the FDA 510(k) for Socrates Aspiration System (Socrates 70 Aspiration Catheter), submitted by Scientia Vascular, Inc.. FDA's decision date was Jul 16, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Socrates Aspiration System (Socrates 70 Aspiration Catheter)?

Scientia Vascular, Inc., based in West Valley City, UT, is the applicant of record for K260002.

How long did the K260002 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Jul 16, 2026, 195 days later.

← All decisions in July 2026

Sources