510(k) K934624

ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE by Advanced Cardiovascular Systems, Inc. — Product Code DYB

K934624 is an FDA 510(k) premarket notification submitted by Advanced Cardiovascular Systems, Inc. for the device "ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE". The FDA issued a decision of Substantially Equivalent on April 13, 1994. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Advanced Cardiovascular Systems, Inc. has at least 10 other 510(k) clearances on record.