PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)

PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) is an FDA 510(k)-cleared medical device (K882879) manufactured by Pioneering Technologies, Inc.. 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 11, 1988. Regulation: 8.