Sniper Infusion Catheter with Balloon Occlusion

Sniper Infusion Catheter with Balloon Occlusion is an FDA 510(k)-cleared medical device (K180904) manufactured by Embolx, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2018. Regulation: 8.