FDA Registration
Active
🇺🇸 United States
Datascope Corp
Reg #: 3007965489
·
FEI: 3007965489
·
Expires 2026
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Datascope Corp
- Registration Number
- 3007965489
- FEI Number
- 3007965489
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 45 Barbour Pond Drive
- City
- Wayne
- State
- NJ
- ZIP
- 07470
- Country
- US
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 | 2012-09-18 |
Proprietary Names
MEGA 7.5FR. 30cc Intra-Aortic Balloon Catheter & Accessories
SENSATION PLUS 8Fr. 50cc IAB Catheter & Accessories
MEGA 8Fr. 50cc IAB Catheter & Accessories
CS300
CS100/CS100i
CARDIOSAVE Li-Ion Battery Transport and Storage Case
CARDIOSAVE Rescue Intra-Aortic Balloon Pump
SENSATION 7Fr. IAB Catheter & Accessories
CS300 Intra-Aortic Balloon Pump
Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP)
LINEAR 7.5Fr. IAB Catheter & Accessories
SENSATION PLUS 7.5Fr. 40cc IAB Catheter & Accessories
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)