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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 / June 2026 / K261549

510(k) cleared

BOBBY Balloon Guide Catheter

MicroVention, Inc., d/b/a Terumo Neuro · Jun 9, 2026 · K261549

FDA cleared the BOBBY Balloon Guide Catheter from MicroVention, Inc., d/b/a Terumo Neuro on Jun 9, 2026 under K261549, a special 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 11, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

MicroVention, Inc., d/b/a Terumo Neuro has one other decision in the tracker over the last 12 months: K261808 (ISAAC Neurovascular Navigation Catheter).

Questions & Answers

What did FDA clear under K261549?

K261549 is the FDA 510(k) for BOBBY Balloon Guide Catheter, submitted by MicroVention, Inc., d/b/a Terumo Neuro. FDA's decision date was Jun 9, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the BOBBY Balloon Guide Catheter?

MicroVention, Inc., d/b/a Terumo Neuro, based in Aliso Viejo, CA, is the applicant of record for K261549.

How long did the K261549 review take?

FDA received the submission on May 11, 2026 and issued its decision on Jun 9, 2026, 29 days later.

← All decisions in June 2026

Sources