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FDA 510(k) approval for EndoSonics:

This article was originally published in Clinica

Executive Summary

The FDA has awarded 510(k) marketing clearance to EndoSonics' FloWire 300 and FloWire 300XT Doppler guide wires. Both models are designed to enable catheter exchanges during cardiovascular intervention, allowing stent deployment and alternative balloon therapies. Physicians can begin a procedure with one catheter and then switch to a different catheter or stent during the procedure without removing the FloWire. The wires are for use in conjunction with the Cardiometrics FloMap Functional Assessment products.

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