BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I

BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I is an FDA 510(k)-cleared medical device (K020834) manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 2002. Regulation: 8.