510(k) K991137

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER by Minntech Corp. — Product Code DTR

K991137 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER". The FDA issued a decision of Substantially Equivalent on June 8, 2000. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Minntech Corp. has at least 10 other 510(k) clearances on record.