510(k) K012225

ATTAIN 6215 VENOGRAM BALLOON CATHETER by Medtronic Vascular — Product Code DYG

K012225 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "ATTAIN 6215 VENOGRAM BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on August 28, 2001. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Medtronic Vascular has at least 10 other 510(k) clearances on record.