510(k) K894721

TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE by The Traumafuse Co. — Product Code DWE

K894721 is an FDA 510(k) premarket notification submitted by The Traumafuse Co. for the device "TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE". The FDA issued a decision of Substantially Equivalent on October 20, 1989. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. The Traumafuse Co. has at least 3 other 510(k) clearances on record.