About This 510(k) Submission
K182735 is an FDA 510(k) clearance for the Paragonix SherpaPak Cardiac Transport System, a System And Accessories, Isolated Heart, Transport And Preservation (Class II — Special Controls, product code MSB), submitted by Paragonix Technologies (Braintree, US). The FDA issued a Cleared decision on October 19, 2018, 21 days after receiving the submission on September 28, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.