Class Class II
HARBOR Occlusion Device (K250133)
Description
HARBOR Occlusion Device by Nuvascular, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250133
Clearance Date2025-07-09
Clearance TypeTraditional
Product CodeKRD
Regulation Number870.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250133
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HARBOR Occlusion Device (K250133) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K113658 | AMPLATZER VASCULAR PLUG 4 | Aga Medical Corp. | 2012 |
| K031810 | AMPLATZER VASCULAR PLUG | Aga Medical Corp. | 2003 |
Trace the full predicate network for K250133
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.