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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 / February 2026 / K260292

510(k) cleared

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

Atraverse Medical · Feb 27, 2026 · K260292 · In the directory

FDA cleared the HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) from Atraverse Medical on Feb 27, 2026 under K260292, a special 510(k) reviewed through the Third Party Review Program. The device falls under product code DXF, Catheter, Septostomy, regulated at 21 CFR 870.5175 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 29, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Atraverse Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260292?

K260292 is the FDA 510(k) for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX), submitted by Atraverse Medical. FDA's decision date was Feb 27, 2026, under product code DXF (Catheter, Septostomy).

Who makes the HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

Atraverse Medical, based in Cardiff By The Sea, CA, is the applicant of record for K260292. The company is listed in the MedDevice Startups directory.

How long did the K260292 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Feb 27, 2026, 29 days later.

← All decisions in February 2026

Sources

In the startup directory

Atraverse Medical

Cardiovascular · Cardiff by the Sea, CA