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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

OrbusNeich Medical (Shenzhen) Co., Ltd. has one other decision in the tracker over the last 12 months: K261778 (JADE SCORE PTA Scoring Balloon Dilatation Catheter).

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

Sources