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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 / K260635

510(k) cleared

HARBOR Occlusion Device

Nuvascular, Inc. · Jun 12, 2026 · K260635

FDA cleared the HARBOR Occlusion Device from Nuvascular, Inc. on Jun 12, 2026 under K260635, a traditional 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 26, 2026. The decision came 106 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 Nuvascular, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260635?

K260635 is the FDA 510(k) for HARBOR Occlusion Device, submitted by Nuvascular, Inc.. FDA's decision date was Jun 12, 2026, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the HARBOR Occlusion Device?

Nuvascular, Inc., based in Irvine, CA, is the applicant of record for K260635.

How long did the K260635 review take?

FDA received the submission on Feb 26, 2026 and issued its decision on Jun 12, 2026, 106 days later.

← All decisions in June 2026