PS MEDICAL IPI VASCULAR ACCESS CATHETER

PS MEDICAL IPI VASCULAR ACCESS CATHETER is an FDA 510(k)-cleared medical device (K954409) manufactured by Pudenz-Schulte Medical Research Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 1995. Regulation: 8.