CBIS CATHETER PULL-BACK DEVICE

CBIS CATHETER PULL-BACK DEVICE is an FDA 510(k)-cleared medical device (K921879) manufactured by Cardiovascular Imaging 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 July 15, 1992. Regulation: 8.