Cerus Endovascular Receives FDA’s 510(k) Clearance for its 027 Micro-Catheter

Cerus Endovascular has received the FDA’s 510(k) marketing clearance for its 027 micro-catheters, which are available in two lengths.

Cerus, which previously received FDA clearance for its 021 micro-catheter platform, expects to submit both for a CE mark under the new EU Medical Devices Regulation later this year.

The company is planning a limited U.S. market release of the 027 micro-catheters in the second quarter of this year, with the 021 micro-catheters platform to follow shortly afterward.