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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 / June 2026 / K261745

510(k) cleared

LightningWire Transseptal Puncture System (TPS)

ElectroWire Medical · Jun 26, 2026 · K261745

FDA cleared the LightningWire Transseptal Puncture System (TPS) from ElectroWire Medical on Jun 26, 2026 under K261745, a traditional 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 May 27, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K261745?

K261745 is the FDA 510(k) for LightningWire Transseptal Puncture System (TPS), submitted by ElectroWire Medical. FDA's decision date was Jun 26, 2026, under product code DXF (Catheter, Septostomy).

Who makes the LightningWire Transseptal Puncture System (TPS)?

ElectroWire Medical, based in Lexington, SC, is the applicant of record for K261745.

How long did the K261745 review take?

FDA received the submission on May 27, 2026 and issued its decision on Jun 26, 2026, 30 days later.

← All decisions in June 2026