Medical Device Manufacturer · US , Braintree , MA

Paragonix Technologies - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2018

Recent clearances: KIDNEYvault Portable Renal Perfusion System, BAROguard, SherpaPak Pediatric Liver Transport System

5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Paragonix Technologies Gastroenterology & Urology ✕

5 devices
1-5 of 5
Cleared Oct 23, 2024
KIDNEYvault Portable Renal Perfusion System
K234060 · KDN
Gastroenterology & Urology · 306d
Cleared Aug 15, 2023
BAROguard
K223874 · KDN
Gastroenterology & Urology · 235d
Cleared Jul 02, 2020
SherpaPak Pediatric Liver Transport System
K201048 · KDN
Gastroenterology & Urology · 72d
Cleared Dec 20, 2019
Paragonix SherpaPak Pancreas Transport System
K191440 · KDN
Gastroenterology & Urology · 204d
Cleared Oct 19, 2018
Paragonix SherpaPak Cardiac Transport System
K182735 · MSB
Gastroenterology & Urology · 21d
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