HARBOR Occlusion Device— 510(k) K260635
Substantially EquivalentNuvascular, Inc.
FDA 510(k) clearance K260635 for HARBOR Occlusion Device, Substantially Equivalent on 2026-06-12. Applicant: Nuvascular, Inc.. Device class: 2.
Summary
Nuvascular's HARBOR Occlusion Device is filed under KRD, vascular devices for promoting embolization. The record gives no sizes or model numbers.
Class II, 21 CFR 870.3300. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nuvascular filed from Irvine, California. Review took 106 calendar days (February 26 to June 12, 2026).
Clearance details
- Applicant
- Nuvascular, Inc.
- Product code
- Product code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code KRD
view allMore clearances from Nuvascular, Inc.
view allAdverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.