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FDA 510(k)

HARBOR Occlusion Device

K-Number: K260635 · 2026-06-12

ApplicantNuvascular, Inc.
Decision Date2026-06-12
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HARBOR Occlusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Nuvascular, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K260635. 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 2026-06-12. The listed applicant is Nuvascular, Inc.. The 510(k) number is K260635.

When did HARBOR Occlusion Device receive FDA 510(k) clearance?

HARBOR Occlusion Device received FDA 510(k) clearance on 2026-06-12, under 510(k) number K260635.

Who is the listed applicant for HARBOR Occlusion Device?

The FDA 510(k) record lists Nuvascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARBOR Occlusion Device?

The FDA product code for HARBOR Occlusion Device is KRD.

Other records listing Nuvascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250133HARBOR Occlusion Device

Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.K253677Tembo Embolic SystemInstylla, Inc.K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation

Official Source

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

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