510(k) K803102

ARTERIAL BUBBLE TRAP K-20 by Delta Medical Industries — Product Code KRL

K803102 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "ARTERIAL BUBBLE TRAP K-20". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code KRL (Detector, Bubble, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4205. Delta Medical Industries has at least 10 other 510(k) clearances on record.