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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 / September 2025 / K251158

510(k) cleared

PowerWire® 14 Radiofrequency Guidewire Kit

Baylis Medical Technologies, Inc. · Sep 11, 2025 · K251158

FDA cleared the PowerWire® 14 Radiofrequency Guidewire Kit from Baylis Medical Technologies, Inc. on Sep 11, 2025 under K251158, a traditional 510(k). The device falls under product code PDU, Catheter For Crossing Total Occlusions, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 15, 2025. The decision came 149 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Baylis Medical Technologies, Inc. has 2 other decisions in the tracker over the last 12 months: K254114 (Baylis Connector Cable), K250275 (PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch).

Questions & Answers

What did FDA clear under K251158?

K251158 is the FDA 510(k) for PowerWire® 14 Radiofrequency Guidewire Kit, submitted by Baylis Medical Technologies, Inc.. FDA's decision date was Sep 11, 2025, under product code PDU (Catheter For Crossing Total Occlusions).

Who makes the PowerWire® 14 Radiofrequency Guidewire Kit?

Baylis Medical Technologies, Inc., based in Mississauga, is the applicant of record for K251158.

How long did the K251158 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Sep 11, 2025, 149 days later.

← All decisions in September 2025

Sources