510(k) K081573

MEDTRONIC EXPORT AP CATHETER by Medtronic Vascular — Product Code DXE

K081573 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC EXPORT AP CATHETER". The FDA issued a decision of Substantially Equivalent on June 27, 2008. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Medtronic Vascular has at least 10 other 510(k) clearances on record.