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# CathWorks 510(k) for Fractional Flow Reserve Device
- URL: https://www.fdaweb.com/cathworks-510-k-for-fractional-flow-reserve-device/
- Published: 2018-08-27T12:00:00.000Z
- Updated: 2026-09-15T00:28:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142205

CathWorks has submitted a 510(k) for its CathWorks FFRangio System, a fractional flow reserve (FFR) device that is intended to deliver objective multi-vessel physiologic measurements to optimize and confirm intraprocedural percutaneous coronary intervention therapy decisions. “The FAME trials clearly demonstrated the clinical and economic value of FFR in PCI decision-making,” the company says. “We expect the system to make non-invasive, wire-free FFR possible in coronary angiograms; reducing wire-related risks and costs,” it adds.