510(k) K810924

MEDRAD HIGH PRESSURE CONECTING TUBE by Medrad, Inc. — Product Code DWE

K810924 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD HIGH PRESSURE CONECTING TUBE". The FDA issued a decision of Substantially Equivalent on April 17, 1981. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Medrad, Inc. has at least 10 other 510(k) clearances on record.