Optease Vena Cava Filter and Retrieval Catheter

• • Terminated Z-0081-2014 FDA Class II ·initiated 27 Sep 2013

  Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter.

• • Terminated Z-1887-2013 FDA Class I ·initiated 29 Mar 2013

  Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.

510(k) Number

K091077 ↗

FDA Product Code

DTK

Device Class

Class II

Regulation

21 CFR Part 870.3375

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cordis Corp., A Johnson & Johnson Co. →