510(k) K852914

ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION by Norton Performance Plastics Corp. — Product Code DQY

K852914 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION". The FDA issued a decision of Substantially Equivalent on September 25, 1985. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.