FDA Registration
Active
🇺🇸 United States
Impella CP Introducer
Reg #: 1220648
·
FEI: 1220648
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ABIOMED, INC.
- Registration Number
- 1220648
- FEI Number
- 1220648
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 22 Cherry Hill Dr
- City
- DANVERS
- State
- MA
- ZIP
- 01923
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192769
Owner / Operator
- Firm Name
- ABIOMED, INC.
- Operator Number
- 1220648
- Address
- 22 CHERRY HILL DR., --
- City
- Danvers
- State
- MA
- Postal Code
- 01923
- Country
- US
- Correspondent
- Anshul Shah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2020-01-21 |
Proprietary Names
Impella CP Introducer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility