About This 510(k) Submission
K143074 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. (Braintree, US). The FDA issued a Cleared decision on November 25, 2014, 29 days after receiving the submission on October 27, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.