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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K254035

510(k) cleared

Mayumi Thrombectomy System

MicroVention, Inc., d/b/a Terumo Neuro · Sep 3, 2026 · K254035

FDA cleared the Mayumi Thrombectomy System from MicroVention, Inc., d/b/a Terumo Neuro on Sep 3, 2026 under K254035, a traditional 510(k). The device falls under product code QEZ, Aspiration Thrombectomy Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 16, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

MicroVention, Inc., d/b/a Terumo Neuro has 2 other decisions in the tracker over the last 12 months: K261808 (ISAAC Neurovascular Navigation Catheter), K261549 (BOBBY Balloon Guide Catheter).

Questions & Answers

What did FDA clear under K254035?

K254035 is the FDA 510(k) for Mayumi Thrombectomy System, submitted by MicroVention, Inc., d/b/a Terumo Neuro. FDA's decision date was Sep 3, 2026, under product code QEZ (Aspiration Thrombectomy Catheter).

Who makes the Mayumi Thrombectomy System?

MicroVention, Inc., d/b/a Terumo Neuro, based in Aliso Viejo, CA, is the applicant of record for K254035.

How long did the K254035 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Sep 3, 2026, 261 days later.

← All decisions in September 2026

Sources