Paragonix Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BAROguard Donor Lung Preservation System, SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
7
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Paragonix Technologies, Inc. Gastroenterology & Urology ✕
7 devices
Cleared
Jan 30, 2026
BAROguard Donor Lung Preservation System
Gastroenterology & Urology
30d
Cleared
Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Gastroenterology & Urology
65d
Cleared
Nov 25, 2014
Sherpa Pak Kidney Transport System
Gastroenterology & Urology
33d
Cleared
Nov 25, 2014
Sherpa Pak Cardiac Transport System
Gastroenterology & Urology
29d
Cleared
May 23, 2014
SHERPA PAK TRANSPORTER
Gastroenterology & Urology
171d
Cleared
Feb 21, 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
Gastroenterology & Urology
108d
Cleared
Feb 06, 2013
SHERPA PAK CARDIAC TRANSPORT SYSTEM
Gastroenterology & Urology
103d