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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 / K253361

510(k) cleared

Teleport Glide Microcatheter

OrbusNeich Medical (Shenzhen) Co., Ltd. · Apr 10, 2026 · K253361

FDA cleared the Teleport Glide Microcatheter from OrbusNeich Medical (Shenzhen) Co., Ltd. on Apr 10, 2026 under K253361, a traditional 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 30, 2025. The decision came 192 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 OrbusNeich Medical (Shenzhen) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253361?

K253361 is the FDA 510(k) for Teleport Glide Microcatheter, submitted by OrbusNeich Medical (Shenzhen) Co., Ltd.. FDA's decision date was Apr 10, 2026, under product code DQY (Catheter, Percutaneous).

Who makes the Teleport Glide Microcatheter?

OrbusNeich Medical (Shenzhen) Co., Ltd., based in Shenzhen, is the applicant of record for K253361.

How long did the K253361 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Apr 10, 2026, 192 days later.

← All decisions in April 2026