H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) is an FDA 510(k)-cleared medical device (K961752) manufactured by Ackrad Laboratories. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 1996. Regulation: 8.