FDA Registration
Active
🇺🇸 United States
On-X Heart Valve Instrumentation
Reg #: 1063481
·
FEI: 3001451326
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Artivion, Inc.
- Registration Number
- 1063481
- FEI Number
- 3001451326
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1655 Roberts Blvd NW
- City
- Kennesaw
- State
- GA
- ZIP
- 30144
- Country
- US
Owner / Operator
- Firm Name
- Artivion, Inc.
- Operator Number
- 9003683
- Address
- 1655 ROBERTS BLVD., N.W., --
- City
- Kennesaw
- State
- GA
- Postal Code
- 30144
- Country
- US
- Correspondent
- Drew Green
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 2016-05-13 |
Proprietary Names
On-X Heart Valve Instrumentation
Establishment Types
Complaint File Establishment per 21 CFR 820.198