FDA Registration
Active
🇺🇸 United States
Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP)
Reg #: 2249723
·
FEI: 3001418283
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Datascope Corp.
- Registration Number
- 2249723
- FEI Number
- 3001418283
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1300 Macarthur Blvd
- City
- MAHWAH
- State
- NJ
- ZIP
- 07430
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181122
Owner / Operator
- Firm Name
- Datascope Corp.
- Operator Number
- 2221819
- Address
- 45 Barbour Pond Drive
- City
- Wayne
- State
- NJ
- Postal Code
- 07470
- Country
- US
- Correspondent
- Elliott Jang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Balloon, Intra-Aortic And Control | DSP | Class 2 | Cardiovascular | No | 2020-08-18 |
Proprietary Names
Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP)
Establishment Types
Manufacture Medical Device