Cleared Traditional

SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

K180194 · Paragonix Technologies, Inc. · Gastroenterology & Urology

Mar 2018

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K180194 is an FDA 510(k) clearance for the SherpaPak Cardiac Transport System and SherpaPak Kidney 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 March 30, 2018, 65 days after receiving the submission on January 24, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.

Submission Details

510(k) Number	K180194 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2018
Decision Date	March 30, 2018
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	MSB — System And Accessories, Isolated Heart, Transport And Preservation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5880