510(k) K241711

Oscar Peripheral Multifunctional Catheter system by Biotronik, Inc. — Product Code LIT

K241711 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "Oscar Peripheral Multifunctional Catheter system". The FDA issued a decision of Substantially Equivalent on July 11, 2024. 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.