FDA Registration
Active
🇺🇸 United States
HexaPulse PF Generator - AFR-00008
Reg #: 3004105270
·
FEI: 3004105270
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PLEXUS CORP.
- Registration Number
- 3004105270
- FEI Number
- 3004105270
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2400 Millbrook Dr
- City
- BUFFALO GROVE
- State
- IL
- ZIP
- 60089
- Country
- US
Regulatory Submissions
- PMA Number
- P240013
Owner / Operator
- Firm Name
- PLEXUS CORP.
- Operator Number
- 3019588
- Address
- ONE PLEXUS WAY, --
- City
- Neenah
- State
- WI
- Postal Code
- 54956
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2025-06-30 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2025-06-30 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2025-06-30 |
Proprietary Names
HexaPulse PF Generator - AFR-00008
HexaFlow Irrigation Pump - AFR-00005
HexaGen RF Generator - AFR-00004
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)