Phenom Catheters

Phenom Catheters is an FDA 510(k)-cleared medical device (K210230) manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2021. Regulation: 8.