FDA Registration
Active
🇺🇸 United States
Lutonix5247 (MN) - Lutonix 014 Drug Coated Balloon PTCA Catheter
Reg #: 2183744
·
FEI: 2183744
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 2183744
- FEI Number
- 2183744
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 380 90TH AVE NW
- City
- Minneapolis
- State
- MN
- ZIP
- 55433
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2017-08-30 |
Proprietary Names
Lutonix5247 (MN) - Lutonix 014 Drug Coated Balloon PTCA Catheter
Establishment Types
Manufacture Device in the United States for Export Only