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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 / May 2026 / K260304

510(k) cleared

WAVE PTA Balloon Catheter

WAVE Medical AG · May 20, 2026 · K260304

FDA cleared the WAVE PTA Balloon Catheter from WAVE Medical AG on May 20, 2026 under K260304, a traditional 510(k). The device falls under product code LIT, Catheter, Angioplasty, Peripheral, Transluminal, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 30, 2026. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K260304?

K260304 is the FDA 510(k) for WAVE PTA Balloon Catheter, submitted by WAVE Medical AG. FDA's decision date was May 20, 2026, under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal).

Who makes the WAVE PTA Balloon Catheter?

WAVE Medical AG, based in Neuhausen Am Rheinfall, is the applicant of record for K260304.

How long did the K260304 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on May 20, 2026, 110 days later.

← All decisions in May 2026