NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING is an FDA 510(k)-cleared medical device (K914489) manufactured by Telectronics Pacing Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 16, 1992. Regulation: 8.