FDA Registration
Active
🇺🇸 United States
Lutonix5247 (MN) - Lutonix 018 Drug Coated Balloon PTA Catheter
Reg #: 2183744
·
FEI: 2183744
·
Expires 2025
Products
1
Proprietary Names
2
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
Regulatory Submissions
- PMA Number
- P130024
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 |
|---|---|---|---|---|---|
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | Class 3 | Unknown | No | 2014-11-11 |
Proprietary Names
Lutonix5247 (MN) - Lutonix 018 Drug Coated Balloon PTA Catheter
Lutonix5247 (MN) - Lutonix 035 Drug Coated Balloon PTA Catheter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)