FDA Registration
Active
🇺🇸 United States
SafeBreak Vascular
Reg #: 3019511659
·
FEI: 3019511659
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- LINEUS MEDICAL
- Registration Number
- 3019511659
- FEI Number
- 3019511659
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 179 North Church Avenue, Suite 202
- City
- Fayetteville
- State
- AR
- ZIP
- 72701
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222791
Owner / Operator
- Firm Name
- Lineus Medical
- Operator Number
- 10082114
- Address
- 179 North Church Avenue, Suite 202
- City
- Fayetteville
- State
- AR
- Postal Code
- 72701
- Country
- US
- Correspondent
- Vance Clement
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intravenous Catheter Force-Activated Separation Device. | QOI | Class 2 | General Hospital | No | 2023-12-08 |
Proprietary Names
SafeBreak Vascular
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198