FDA Registration
Active
🇺🇸 United States
Revolution Peripheral Atherectomy System
Reg #: 3003862657
·
FEI: 3003862657
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- REX MEDICAL LP
- Registration Number
- 3003862657
- FEI Number
- 3003862657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1100 E Hector St Ste 396
- City
- CONSHOHOCKEN
- State
- PA
- ZIP
- 19428
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212351
Owner / Operator
- Firm Name
- REX MEDICAL LP
- Operator Number
- 9050497
- Address
- 1100 E Hector St, Ste 396
- City
- Conshohocken
- State
- PA
- Postal Code
- 19428
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2024-12-11 |
Proprietary Names
Revolution Peripheral Atherectomy System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility