MODEL 2188 CORONARY SINUS LEAD.

MODEL 2188 CORONARY SINUS LEAD. is an FDA 510(k)-cleared medical device (K961936) 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 August 14, 1996. Regulation: 8.