510(k) K042445

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT by Bard Access Systems, Inc. — Product Code ITX

K042445 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT". The FDA issued a decision of Substantially Equivalent on October 19, 2004. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.