Data / Medical devices / Israel / Cathworks Ltd.
Cathworks Ltd.: FDA-registered device maker in Kfar Saba, Israel, 2 510(k) clearances
Cathworks Ltd. is registered with the FDA (registration 3014129161) in Kfar Saba, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 9, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014129161
- Address
- 3 Rapaport Street, Kfar Saba, Israel, 4465141
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- May 19, 2026
- Registered through
- 2026
- Brand names listed
- FFRangio, FFRangio System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Angiographic Coronary Vascular Physiologic Simulation Software | QEK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 9, 2019 | K192442 | FFRangio | QEK | Substantially Equivalent | Cathworks, Ltd. | accessdata.fda.gov |
| December 19, 2018 | K182149 | FFRangio System | QEK | Substantially Equivalent | Cathworks, Ltd. | accessdata.fda.gov |
Updated December 9, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.