# K250133: HARBOR Occlusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Nuvascular, Inc.
- Decided: Jul 9, 2025 after 173 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K891688 (1989). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113658: Amplatzer Vascular Plug 4, Aga Medical Corp. (2012) Summary page 5.
- K031810: Amplatzer Vascular Plug, Aga Medical Corp. (2003) Summary page 5.

## Most influential descendants
- K260635: HARBOR Occlusion Device (2026), 0 descendants of its own

## Indications for use
The HARBOR Occlusion Device is indicated for arterial embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K250133
Methodology: https://510kreport.com/methodology