TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS

TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS is an FDA 510(k)-cleared medical device (K822598) manufactured by Vertex Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 1982. Regulation: 8.