510(k) K993001

COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED by Cobe Cardiovascular, Inc. — Product Code DTN

K993001 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED". The FDA issued a decision of Substantially Equivalent on December 3, 1999. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Cobe Cardiovascular, Inc. has at least 10 other 510(k) clearances on record.