FDA 483 - Bard Access Systems, Inc. (BAS) - August 21, 2092

This document is not an FDA Form 483 inspectional observation report. Instead, it contains correspondence and documentation related to Bard Access Systems, Inc.'s 510(k) premarket notification (K924250) for a Plastic Low Profile Subcutaneous Port, located in Salt Lake City, UT. The FDA determined the device was substantially equivalent, allowing it to be marketed, and therefore no inspectional observations or violations were cited in this context.