KSEA MODEL 383320 20 ANGIOMAT

KSEA MODEL 383320 20 ANGIOMAT is an FDA 510(k)-cleared medical device (K960486) manufactured by Karl Storz Endoscopy. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 1996. Regulation: 8.