cath.worksFFRangio
CathWorks Ltd
CATHWORKS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015192387 | 3015192387 | CATHWORKS | 1 | N | 2026-01-01 | 4000 MacArthur Blvd Suite 1025 - East Tower Newport Beach CA US 92660 |
| 3015192387 | 3015192387 | CATHWORKS | 1 | Y | 2020-04-25 | 65 Enterprise 3rd Floor Aliso Viejo CA US 92656 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290017855028 | FFRangio - The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of a coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The FFRangio™ System performs all required processing and calculations based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure. | 949-330-6900 | Jim.corbett@cath.works |
| 07290017855028 | FFRangio - The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of a coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The FFRangio™ System performs all required processing and calculations based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure. | 949-330-6900 | eleanor.jackson@cath.works |
| 07290017855059 | FFRangio - The FFRangio System is a non invasive image based software device | +972 545649707 | reut.magen@cath.works |
| 07290017855059 | FFRangio - The FFRangio System is a non invasive image based software device | 949-330-6900 | ayelet.peer@cath.works |
| 17290017855025 | FFRangio - The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative ana | 949-330-6900 | Jim.corbett@cath.works |
| 17290017855056 | FFRangio - The FFRangio System is a non invasive image based software device | 949-330-6900 | ayelet.peer@cath.works |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 350984 | 2009318755 | K192442 | FFRangio | QEK | 2019-12-09 |
| 350984 | 1093149385 | K182149 | FFRangio System | QEK | 2018-12-19 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QEK | 2 | 2019-12-09 |
PMN#
FFRangio System
CathWorks Ltd
GUDID#
FFRangio - The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of a coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The FFRangio™ System performs all required processing and calculations based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure.
2019-02-12
FFRangio - The FFRangio System is a non invasive image based software device
2019-12-26
FFRangio - The FFRangio System is a non invasive image based software device
2019-12-26
FFRangio - The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative ana
2019-02-12