SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System— 510(k) K180194

Name: FDA 510(k) clearance K180194
Creator: U.S. Food and Drug Administration
Published: 2018-03-30

Substantially Equivalent

Paragonix Technologies, Inc.

FDA 510(k) clearance K180194 for SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System, Substantially Equivalent on 2018-03-30. Applicant: Paragonix Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Paragonix Technologies, Inc.
Product code: Code MSB
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-24
Decision date: 2018-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.