Micropuncture Introducer Sets; Micropuncture Pedal Access Sets

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets is an FDA 510(k)-cleared medical device (K240589) manufactured by Cook Medical. 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 24, 2024. Regulation: 8.