510(k) K133539

TOTAL ACROSS by Medtronic Vascular — Product Code DQY

K133539 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "TOTAL ACROSS". The FDA issued a decision of Substantially Equivalent on March 26, 2014. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronic Vascular has at least 10 other 510(k) clearances on record.