PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET

PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET is an FDA 510(k)-cleared medical device (K961513) manufactured by Ep Medsystems. 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 12, 1996. Regulation: 8.