FDA Registration
Active
🇺🇸 United States
CrossFAST Integrated Microcatheter Guide Extension System
Reg #: 3032277090
·
FEI: 3032277090
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- VANTIS VASCULAR, INC.
- Registration Number
- 3032277090
- FEI Number
- 3032277090
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2570 N 1st St Ste 200
- City
- San Jose
- State
- CA
- ZIP
- 95131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242276
Owner / Operator
- Firm Name
- Vantis Vascular, Inc.
- Operator Number
- 10091990
- Address
- 2570 N First St. Suite 200
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- Mai-Ly Wilcox
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-11-22 |
Proprietary Names
CrossFAST Integrated Microcatheter Guide Extension System
CrossFAST Integrated Microcatheter Advanced Delivery System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility