FDA Registration
Active
🇺🇸 United States
CorPath GRX Extended Reach Arm
Reg #: 3022099867
·
FEI: 3022099867
·
Expires 2025
Products
1
Proprietary Names
9
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
- K173288
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 | 2018-02-20 |
Proprietary Names
CorPath GRX Extended Reach Arm
CorPath GRX Control Console
CorPath GRX
CorPath GRX Robotic Drive
CorPath Robotic-Assisted System
CorPath GRX Drive Gear
CorPath GRX Cassette
CorPath
CorPath GRX System
Establishment Types
Manufacture Medical Device