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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 / April 2026 / K253832

510(k) cleared

Dilation Balloon Catheter

Mirco-Tech (Nanjing) Co., Ltd. · Apr 24, 2026 · K253832

FDA cleared the Dilation Balloon Catheter from Mirco-Tech (Nanjing) Co., Ltd. on Apr 24, 2026 under K253832, a traditional 510(k). The device falls under product code FGE, Stents, Drains And Dilators For The Biliary Ducts, regulated at 21 CFR 876.5010 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 1, 2025. The decision came 144 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mirco-Tech (Nanjing) Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K260262 (Injection Needle), K254153 (Single-use Video Scope; PB Digital Controller), K253139 (Disposable Distal Cap).

Questions & Answers

What did FDA clear under K253832?

K253832 is the FDA 510(k) for Dilation Balloon Catheter, submitted by Mirco-Tech (Nanjing) Co., Ltd.. FDA's decision date was Apr 24, 2026, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the Dilation Balloon Catheter?

Mirco-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K253832.

How long did the K253832 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Apr 24, 2026, 144 days later.

← All decisions in April 2026

Sources