510(k) K900339

HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES by Shiley, Inc. — Product Code DTS

K900339 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES". The FDA issued a decision of Substantially Equivalent on March 28, 1990. The device falls under product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4420. Shiley, Inc. has at least 10 other 510(k) clearances on record.