Cleared Traditional

HARBOR Occlusion Device

K250133 · Nuvascular, Inc. · Cardiovascular

Jul 2025

Decision

173d

Days

Class 2

Risk

About This 510(k) Submission

K250133 is an FDA 510(k) clearance for the HARBOR Occlusion Device, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Nuvascular, Inc. (Irvine, US). The FDA issued a Cleared decision on July 9, 2025, 173 days after receiving the submission on January 17, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number	K250133 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2025
Decision Date	July 09, 2025
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF