FDA Registration
Active
🇺🇸 United States
SCIENTIA VASCULAR
Reg #: 3009546466
·
FEI: 3009546466
·
Expires 2026
Products
7
Proprietary Names
11
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- SCIENTIA VASCULAR
- Registration Number
- 3009546466
- FEI Number
- 3009546466
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2460 South 3270 West
- City
- West Valley City
- State
- UT
- ZIP
- 84119
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143398
Owner / Operator
- Firm Name
- Scientia Vascular
- Operator Number
- 10040465
- Address
- 2460 South 3270 West
- City
- West Valley City
- State
- UT
- Postal Code
- 84119
- Country
- US
- Correspondent
- Amy McManus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2016-08-18 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2019-12-05 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-12-05 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-09-24 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2021-09-24 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2017-04-19 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2023-10-20 |
Proprietary Names
Plato MICROCATH 27B Microcatheter
Aristotle 18 Guidewire
Plato 17 Microcatheter
Aristotle 14 Guidewire
Zoom Wire 14 Guidewire
Aristotle Colossus Guidewire
Aristotle 24 Guidewire
Plato MICROCATH 27 Microcatheter
Socrates Aspiration System
Socrates 38 Catheter
Volo 14 Guidewire
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only