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FDA 510(k)

HARBOR Occlusion Device

K-Number: K250133 · 2025-07-09

ApplicantNuvascular, Inc.
Decision Date2025-07-09
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HARBOR Occlusion Device is a medical device manufactured by Nuvascular, Inc.. It received FDA 510(k) clearance on 2025-07-09 under approval number K250133. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARBOR Occlusion Device?

HARBOR Occlusion Device is a medical device that received FDA 510(k) clearance on 2025-07-09. It is manufactured by Nuvascular, Inc.. The 510(k) number is K250133.

When was HARBOR Occlusion Device approved by the FDA?

HARBOR Occlusion Device received FDA 510(k) clearance on 2025-07-09, under approval number K250133.

What company makes HARBOR Occlusion Device?

HARBOR Occlusion Device is manufactured by Nuvascular, Inc..

What is the FDA product code for HARBOR Occlusion Device?

The FDA product code for HARBOR Occlusion Device is KRD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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