Tag: FDA 510K

22
Sep

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)] submission. Section

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9
Nov

Fish-Skin Tissue Regeneration Technology to Heal Human Wounds

By Regulatory Doctor; LinkedIn; Google Plus; Twitter; Facebook Fish-Skin Tissue Regeneration Technology to Heal Human Wounds On October 23, 2013, the US FDA cleared a 510(k) [K132343] to market a proprietary fish-skin technology, marketed as MariGen Omega3, for the treatment of chronic wounds in the US.  The MariGen Omega3 is manufactured by Kerecis in Iceland from fish locally harvested in the North Atlantic waters.

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