FDA Registration
Active
🇺🇸 United States
Embolx Microcatheter
Reg #: 3011660785
·
FEI: 3011660785
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- EMBOLX INC.
- Registration Number
- 3011660785
- FEI Number
- 3011660785
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 530 Lakeside Dr Ste 150
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142692
Owner / Operator
- Firm Name
- Embolx Inc.
- Operator Number
- 10049613
- Address
- 530 Lakeside Dr Ste 150
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94085
- Country
- US
- Correspondent
- Michael Allen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2015-06-29 |
Proprietary Names
Embolx Microcatheter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device