PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)

PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) is an FDA 510(k)-cleared medical device (K945461) manufactured by Medtronics Interventional Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 1995. Regulation: 8.