FDA Registration
Active
🇺🇸 United States
CONTEGO MEDICAL, INC
Reg #: 3011471056
·
FEI: 3011471056
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- CONTEGO MEDICAL, INC
- Registration Number
- 3011471056
- FEI Number
- 3011471056
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3801 Lake Boone Trail, Suite 100
- City
- Raleigh
- State
- NC
- ZIP
- 27607
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223897
- PMA Number
- P240009
Owner / Operator
- Firm Name
- Contego Medical, INC
- Operator Number
- 10050012
- Address
- 3801 Lake Boone Trail, Suite 100
- City
- Raleigh
- State
- NC
- Postal Code
- 27607
- Country
- US
- Correspondent
- James Clossick
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2024-10-16 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2023-08-15 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2023-08-15 |
| Temporary Carotid Catheter For Embolic Capture | NTE | Class 2 | Cardiovascular | No | 2023-08-15 |
Proprietary Names
Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
Excipio LV Thrombectomy Device
Excipio SV Thrombectomy Device
Excipio Aspiration Catheter and Tubing
Excipio LV Prime Thrombectomy Device
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility