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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 / March 2026 / K260437

510(k) cleared

Valvuloplasty Balloon Catheter (ValvuloPro)

Dongguan TT Medical, Inc. · Mar 20, 2026 · K260437

FDA cleared the Valvuloplasty Balloon Catheter (ValvuloPro) from Dongguan TT Medical, Inc. on Mar 20, 2026 under K260437, a special 510(k). The device falls under product code OZT, Balloon Aortic Valvuloplasty, regulated at 21 CFR 870.1255 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 11, 2026. The decision came 37 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Dongguan TT Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260437?

K260437 is the FDA 510(k) for Valvuloplasty Balloon Catheter (ValvuloPro), submitted by Dongguan TT Medical, Inc.. FDA's decision date was Mar 20, 2026, under product code OZT (Balloon Aortic Valvuloplasty).

Who makes the Valvuloplasty Balloon Catheter (ValvuloPro)?

Dongguan TT Medical, Inc., based in Dongguan, is the applicant of record for K260437.

How long did the K260437 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Mar 20, 2026, 37 days later.

← All decisions in March 2026