510(k) K853791

NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 by Norton Performance Plastics Corp. — Product Code DTR

K853791 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000". The FDA issued a decision of Substantially Equivalent on December 9, 1985. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.