FDA Registration
Active
🇺🇸 United States
Atrium Medical Corporation
Reg #: 3011175548
·
FEI: 3011175548
·
Expires 2026
Products
9
Proprietary Names
18
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Atrium Medical Corporation
- Registration Number
- 3011175548
- FEI Number
- 3011175548
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 40 Continental Blvd
- City
- Merrimack
- State
- NH
- ZIP
- 03054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992960
- PMA Number
- P120003
Owner / Operator
- Firm Name
- ATRIUM MEDICAL CORPORATION
- Operator Number
- 1219977
- Address
- 40 Continental Blvd., --
- City
- Merrimack
- State
- NH
- Postal Code
- 03054
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2011-07-06 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 1993-02-10 |
| Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | DYF | Class 2 | Cardiovascular | No | 2025-06-17 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2023-05-18 |
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2011-07-06 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2015-01-08 |
| Iliac Covered Stent, Arterial | PRL | Class 3 | Unknown | No | 2023-05-18 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2011-04-04 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2006-03-14 |
Proprietary Names
Advanta VXT Vascular Graft
Flixene Vascular Grafts with GW
Atrium Express Chest Drain Single Collection Dry Suction Dry Seal
Atrium Oasis Dry Suction Water Seal Chest Drain
Chest Drain Accessories (Connectors, Suction Bulbs, Suction Connectors and Tube Pack)
Atrium Oasis Chest Drain Infant/Pediatric Collection Dry Suction Water Seal
Atrium Express Mini 500 Chest Drain Single Collection Dry Seal
Flixene Vascular Graft
Advanta VXT Graft
Express BRU Chest Drain
Ocean BRU Chest Drain
Oasis BRU Chest Drain
Thoracic catheters PVC and Firm
Flixene Grafts
Silicone Thoracic Catheters
iCast Covered Stent System
Vascular Graft Tunneling Instrumentation
Advanta V12 Covered Stent System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only