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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K250133
Device Name HARBOR Occlusion Device
Applicant
Nuvascular, Inc.
141 Innovation Dr., Suite 100
Irvine,  CA  92617
Applicant Contact Meadow Wang
Correspondent
Nuvascular, Inc.
141 Innovation Dr., Suite 100
Irvine,  CA  92617
Correspondent Contact Meadow Wang
Regulation Number870.3300
Classification Product Code
KRD  
Date Received01/17/2025
Decision Date 07/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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