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FDA 510k PREMARKET NOTIFICATION A 510k is a premarket submission made to FDA that demonstrates the device to be sold is as safe and effective, that is, substantially equivalent, to a legally marketed device. A technical file, known as 510(k), needs to be submitted to the FDA for devices meant to be used

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Steerable Cardiac Ablation Catheter Remote Control System

FDA Medical Device Classification De Novo

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)]…

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