510(k) K190037

Cronus HP PTA Balloon Catheter by Nipro Medical Corporation — Product Code LIT

K190037 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "Cronus HP PTA Balloon Catheter". The FDA issued a decision of Substantially Equivalent on October 24, 2019. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.