FDA Registration
Active
🇺🇸 United States
IMPEDE Embolization Plug
Reg #: 3013353964
·
FEI: 3013353964
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHAPE MEMORY MEDICAL INC
- Registration Number
- 3013353964
- FEI Number
- 3013353964
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1321 Ridder Park Drive, Suite 10
- City
- San Jose
- State
- CA
- ZIP
- 95131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181051
Owner / Operator
- Firm Name
- Shape Memory Medical Inc
- Operator Number
- 10055775
- Address
- 1321 Ridder Park Drive, Suite 10
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- Meghan L Reu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2018-07-23 |
Proprietary Names
IMPEDE Embolization Plug
Establishment Types
Manufacture Medical Device