40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER is an FDA 510(k)-cleared medical device (K864537) manufactured by Aries Medical, 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 18, 1987. Regulation: 8.