FDA Registration
Active
🇺🇸 United States
HAART 300 Aortic Annuloplasty Device and accessories
Reg #: 3019892983
·
FEI: 3019892983
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Corcym Inc.
- Registration Number
- 3019892983
- FEI Number
- 3019892983
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9800 Mount Pyramid Court, Suite #400
- City
- Englewood
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163608
Owner / Operator
- Firm Name
- Corcym S.r.l.
- Operator Number
- 9083203
- Address
- Via Crescentino sn
- City
- Saluggia
- State
- Vercelli
- Postal Code
- 13040
- Country
- IT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aortic Annuloplasty Ring | PST | Class 2 | Cardiovascular | No | 2023-11-30 |
Proprietary Names
HAART 300 Aortic Annuloplasty Device and accessories
Establishment Types
Manufacture Medical Device