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Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / September 2025 / K252027

510(k) cleared

Vertex(TM) Catheter

Jupiter Endovascular · Sep 12, 2025 · K252027 · In the directory

FDA cleared the Vertex(TM) Catheter from Jupiter Endovascular on Sep 12, 2025 under K252027, a traditional 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 30, 2025. The decision came 74 days later, inside the 90 FDA-day goal for a 510(k).

Jupiter Endovascular has one other decision in the tracker over the last 12 months: K261523 (Vertex Thrombectomy System).

Questions & Answers

What did FDA clear under K252027?

K252027 is the FDA 510(k) for Vertex(TM) Catheter, submitted by Jupiter Endovascular. FDA's decision date was Sep 12, 2025, under product code DYB (Introducer, Catheter).

Who makes the Vertex(TM) Catheter?

Jupiter Endovascular, based in Menlo Park, CA, is the applicant of record for K252027. The company is listed in the MedDevice Startups directory.

How long did the K252027 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Sep 12, 2025, 74 days later.

← All decisions in September 2025

Sources

In the startup directory

Jupiter Endovascular

Cardiovascular · Menlo Park, CA