FDA Registration
Active
🇮🇱 Israel
CATHWORKS LTD.
Reg #: 3014129161
·
FEI: 3014129161
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CATHWORKS LTD.
- Registration Number
- 3014129161
- FEI Number
- 3014129161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 Rapaport, 4th floor
- City
- Kfar Saba Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K192442
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- Medtronic Vascular
- Contact Name
- Tom Reichel
- Address
- 8200 Coral Sea St Ne
- City
- Mounds View
- State
- MN
- ZIP
- 55112
- Country
- US
- [email protected]
- Phone
- 763 5269693
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Angiographic Coronary Vascular Physiologic Simulation Software | QEK | Class 2 | Cardiovascular | No | 2026-06-02 |
Proprietary Names
FFRangio
FFRangio System
Establishment Types
Manufacture Medical Device