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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 / K252122

510(k) cleared

DCwire Micro-guidewire

Shanghai Achieva Medical Suzhou Co., Ltd. · Mar 16, 2026 · K252122

FDA cleared the DCwire Micro-guidewire from Shanghai Achieva Medical Suzhou Co., Ltd. on Mar 16, 2026 under K252122, a traditional 510(k). The device falls under product code MOF, Guide, Wire, Catheter, Neurovasculature, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 7, 2025. The decision came 252 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 Shanghai Achieva Medical Suzhou Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252122?

K252122 is the FDA 510(k) for DCwire Micro-guidewire, submitted by Shanghai Achieva Medical Suzhou Co., Ltd.. FDA's decision date was Mar 16, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the DCwire Micro-guidewire?

Shanghai Achieva Medical Suzhou Co., Ltd., based in Suzhou, is the applicant of record for K252122.

How long did the K252122 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Mar 16, 2026, 252 days later.

← All decisions in March 2026