SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT

About This 510(k) Submission

K042445 is an FDA 510(k) clearance for the SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 19, 2004, 40 days after receiving the submission on September 9, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.