Prestige Coil System (Prestige Packing Line Extension)

Prestige Coil System (Prestige Packing Line Extension) is an FDA 510(k)-cleared medical device (K251383) manufactured by Balt USA, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2025. Regulation: 8.