HARBOR Occlusion Device
FDA 510(k) clearance K250133 · decided 2025-07-09
Clearance details
- K-number
- K250133
- Device name
- HARBOR Occlusion Device
- Applicant
- Nuvascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-17
- Decision date
- 2025-07-09
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- KRD
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UniPearls® Embolic Microspheres (K252812) | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| HARBOR Occlusion Device (K260635) | Nuvascular, Inc. | 2026-06-12 |
| LOBO Vascular Occlusion System (K260508) | Okami Medical, Inc. | 2026-04-10 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
| OBSIDIO™ Conformable Embolic (M0013972101010) (K253376) | Boston Scientific Corporation | 2025-10-30 |
| Polyvinyl Alcohol Embolic Microspheres (K250209) | Canyon Medical, Inc. | 2025-09-23 |
| Prestige Coil System (Prestige Packing Line Extension) (K251383) | Balt USA, LLC | 2025-05-30 |
| Embosphere Microspheres (K250971) | Biosphere Medical, S.A. | 2025-05-16 |
| Nitinol Enhanced Device (NED) (K250276) | Embolization, Inc. | 2025-05-15 |
Recalls involving this device
No recalls on record reference this clearance.