BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP

BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP is an FDA 510(k)-cleared medical device (K983372) manufactured by Sunscope Intl., 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 February 4, 1999. Regulation: 8.