Paragonix SherpaPak Cardiac Transport System— 510(k) K182735

Name: FDA 510(k) clearance K182735
Creator: U.S. Food and Drug Administration
Published: 2018-10-19

Substantially Equivalent

Paragonix Technologies

FDA 510(k) clearance K182735 for Paragonix SherpaPak Cardiac Transport System, Substantially Equivalent on 2018-10-19. Applicant: Paragonix Technologies. Device class: 2.

Clearance details

Applicant: Paragonix Technologies
Product code: Code MSB
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-28
Decision date: 2018-10-19
Decision: Substantially Equivalent
Clearance type: Special
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.