CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT

CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT is an FDA 510(k)-cleared medical device (K023463) manufactured by Cryo Vascular 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 February 18, 2003. Regulation: 8.