MODELS 4012/4512 TRANSVENOUS TINED-

MODELS 4012/4512 TRANSVENOUS TINED- is an FDA 510(k)-cleared medical device (K842032) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 17, 1985. Regulation: 8.