510(k) K123358

PACIFIC PLUS by Medtronic Vascular — Product Code LIT

K123358 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "PACIFIC PLUS". The FDA issued a decision of Substantially Equivalent on January 29, 2013. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Medtronic Vascular has at least 10 other 510(k) clearances on record.