FDA Registration
Active
🇺🇸 United States
Amphirion Deep 014" OTW PTA Balloon Catheter (Shaft Extension)
Reg #: 2183870
·
FEI: 2183870
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Medtronic, Inc.
- Registration Number
- 2183870
- FEI Number
- 2183870
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4600 Nathan Lane North
- City
- Plymouth
- State
- MN
- ZIP
- 55442
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052791
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2012-10-09 |
Proprietary Names
Amphirion Deep 014" OTW PTA Balloon Catheter (Shaft Extension)
Amphirion Deep 014 OTW PTA Balloon Catheter
Amphirion Deep PTA Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility