FDA Registration
Active
🇺🇸 United States
HTTPS://WWW.HJARTA.CARE
Reg #: 3017785723
·
FEI: 3017785723
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- HTTPS://WWW.HJARTA.CARE
- Registration Number
- 3017785723
- FEI Number
- 3017785723
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4617 W. Sleepy Hollow Lane
- City
- Mequon
- State
- WI
- ZIP
- 53092
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN250033
Owner / Operator
- Firm Name
- https://www.hjarta.care
- Operator Number
- 10085118
- Address
- 4617 W. Sleepy Hollow Lane
- City
- Mequon
- State
- WI
- Postal Code
- 53092
- Country
- US
- Correspondent
- brian d thorson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device For Open Surgical Explant Of Endovascular Prostheses | SHR | Class 2 | Cardiovascular | No | 2026-05-06 |
Proprietary Names
XplantR
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility