About This 510(k) Submission
K123326 is an FDA 510(k) clearance for the SHERPA PAK CARDIAC TRANSPORT SYSTEM, a System And Accessories, Isolated Heart, Transport And Preservation (Class II — Special Controls, product code MSB), submitted by Paragonix Technologies, Inc. (Providence, US). The FDA issued a Cleared decision on February 6, 2013, 103 days after receiving the submission on October 26, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.