PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES is an FDA 510(k)-cleared medical device (K003072) manufactured by Biotronik, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 8, 2001. Regulation: 8.