SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE

SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE is an FDA 510(k)-cleared medical device (K955869) manufactured by Scimed Life Systems, 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 March 21, 1996. Regulation: 8.