Harbor
HARBOR is a self-expanding braided nitinol implant intended for arterial embolization in the peripheral vasculature. The filing describes the implant as supplied with components used for…
HARBOR is a self-expanding braided nitinol implant intended for arterial embolization in the peripheral vasculature.
The filing describes the implant as supplied with components used for implantation, with the implant packaged collapsed inside an introducer sheath.
Listed Item
HARBOR Occlusion Device
Device Role
A radiopaque marker band is attached at the implant’s proximal end. The filing describes delivery and implantation in peripheral vasculature under fluoroscopy.
The subject-device attributes identify its function as embolization in the arterial peripheral vasculature and locate it in the peripheral arterial vasculature.
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Suzhou Haowei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Nuvascular Inc., United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Manufacturer |
| 510(k) | K250133 |
| Record published | 2025-07-30 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-08-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04-OCCLUDE-070 | Vessel Diameter 7.0 mm | In distribution |
| 04-OCCLUDE-065 | Vessel Diameter 6.5 mm | In distribution |
| 04-OCCLUDE-025 | Vessel Diameter 2.5 mm | In distribution |
| 04-OCCLUDE-030 | Vessel Diameter 3.0 mm | In distribution |
| 04-OCCLUDE-020 | Vascular Size 2.0 mm | In distribution |
| 04-OCCLUDE-120 | Vessel Diameter 12.0 mm | In distribution |
| 04-OCCLUDE-110 | Vessel Diameter 11.0 mm | In distribution |
| 04-OCCLUDE-040 | Vessel Diameter 4.0 mm | In distribution |
| 04-OCCLUDE-035 | Vascular Size 3.5 mm | In distribution |
| 04-OCCLUDE-080 | Vessel Diameter 8.0 mm | In distribution |
| 04-OCCLUDE-045 | Vessel Diameter 4.5 mm | In distribution |
| 04-OCCLUDE-060 | Vessel Diameter 6.0 mm | In distribution |
| 04-OCCLUDE-050 | Vessel Diameter 5.0 mm | In distribution |
| 04-OCCLUDE-100 | Vessel Diameter 10.0 mm | In distribution |
| 04-OCCLUDE-090 | Vessel Diameter 9.0 mm | Withdrawn |
| 04-OCCLUDE-055 | Vessel Diameter 5.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prestige Coil System | Balt USA, LLC | 339 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 279 |
| Optima Coil System | Balt USA, LLC | 255 |
| AxiumTM | Micro Therapeutics, Inc. | 255 |
| Avenir | Shanghai Wallaby Medical Technologies Co., Inc. | 184 |
| MReye | Cook Incorporated | 167 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 162 |
| Nester | Cook Incorporated | 160 |
| Axium | Micro Therapeutics, Inc. | 146 |
| ConcertoTM | Micro Therapeutics, Inc. | 133 |
| Tornado | Cook Incorporated | 111 |
| V-Trak | MicroVention, Inc. | 105 |
Showing 12 of 158. All products under Device, Vascular, For Promoting Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260635 | 2026-06-12 |
| K250133 | 2025-07-09 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P780011 | 1988-01-29 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.