510(k) K950026

MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER by Medtronics Interventional Vascular — Product Code DQY

K950026 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on April 5, 1995. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronics Interventional Vascular has at least 10 other 510(k) clearances on record.