Jupiter Endovascular's Vertex catheter clears 510(k) in 74 days

MedDevice Startups Staff · Sep 17 · 2 min read · Via MassDevice

FDA cleared Jupiter Endovascular's Vertex catheter on September 12 under K252027. The Menlo Park startup filed on June 30, so the review took 74 days. The clearance is for insertion of endovascular devices, product code DYB. It does not cover the pulmonary embolism indication the company is chasing.

Vertex carries what Jupiter calls Transforming Fixation. The catheter tracks over a guidewire in a flexible state, then pressurizes with saline to hold a firm position inside the vessel. The company describes it as the first cleared intravascular device that can switch from flexible to firm on demand.

Jupiter spun out of Neptune Medical in August 2024 with $21 million, Sonder Capital among the backers, and Carl St. Bernard as CEO. The PE claim rides on SPIRARE II, an IDE trial of up to 145 intermediate-risk patients at up to 25 US and European sites. Clearing the catheter as a general access device first is a familiar split. The hardware gets a K number now; the therapeutic claim waits on data.

Questions & Answers

What did FDA clear under K252027?

K252027 is the 510(k) for Jupiter Endovascular's Vertex catheter, cleared September 12, 2025 under product code DYB. The indication is insertion of endovascular devices, not treatment of pulmonary embolism.

How long did Jupiter Endovascular's Vertex 510(k) take?

FDA received the Vertex 510(k) on June 30, 2025 and cleared it on September 12, 2025, a 74-day review.

Who owns Jupiter Endovascular?

Jupiter Endovascular spun out of Neptune Medical in August 2024 with $21 million in funding and Carl St. Bernard as CEO. It is based in Menlo Park, California.

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