510(k) K222065

Passeo-35 Xeo Peripheral Dilatation Catheter by Biotronik, Inc. — Product Code LIT

K222065 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "Passeo-35 Xeo Peripheral Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on February 16, 2023. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Biotronik, Inc. has at least 10 other 510(k) clearances on record.