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ELECTROPHYSIOLOGY CATHETER 510(K) RESCISSIONS THREATENED BY FDA

This article was originally published in The Gray Sheet

Executive Summary

ELECTROPHYSIOLOGY CATHETER 510(K) RESCISSIONS THREATENED BY FDA for devices with electrode tips greater than 2 millimeters in length. In a Sept. 6 press release, EP Technologies said it received a letter from FDA explaining that "an error had been made in granting clearance on the basis of substantial equivalence with previously cleared devices." The Aug. 29 letter was sent to all manufacturers with 510(k)s for the diagnostic electrophysiology catheters, including Cordis, Bard, and Medtronic.

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