TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000

TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 is an FDA 510(k)-cleared medical device (K904491) manufactured by Lifestream Int'L, 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 January 31, 1991. Regulation: 8.