FDA Registration
Active
🇺🇸 United States
CorPath GRX Extended Reach Arm
Reg #: 3022099867
·
FEI: 3022099867
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Siemens Healthineers Endovascular Robotics, Inc.
- Registration Number
- 3022099867
- FEI Number
- 3022099867
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 275 Grove Street, Suite 1-110
- City
- Newton
- State
- MA
- ZIP
- 02466
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202275
Owner / Operator
- Firm Name
- Siemens Healthineers Endovascular Robotics, Inc.
- Operator Number
- 10039855
- Address
- 275 Grove Street, Suite 1-110
- City
- Newton
- State
- MA
- Postal Code
- 02466
- Country
- US
- Correspondent
- Marites Yamut
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Catheter Control, Steerable | DXX | Class 2 | Cardiovascular | No | 2021-01-04 |
Proprietary Names
CorPath GRX Extended Reach Arm
CorPath GRX System
CorPath GRX with technIQ
technIQ
CorPath GRX Cassette
CorPath GRX
CorPath GRX Control Console
CorPath GRX Drive Gear
CorPath
CorPath GRX Robotic Drive
CorPath GRX System with technIQ
CorPath GRX Robotic-Assisted System
Establishment Types
Manufacture Medical Device