KDN · Class II · 21 CFR 876.5880

FDA Product Code KDN: System, Perfusion, Kidney

Leading manufacturers include Preservation Solutions, Inc., Xvivo Perfusion AB and Paragonix Technologies.

44
Total
44
Cleared
172d
Avg days
1983
Since
44 devices
25–44 of 44
Cleared Nov 25, 2014
Sherpa Pak Kidney Transport System
K143054
Paragonix Technologies, Inc.
Gastroenterology & Urology · 33d
Cleared May 23, 2014
SHERPA PAK TRANSPORTER
K133694
Paragonix Technologies, Inc.
Gastroenterology & Urology · 171d
Cleared Feb 16, 2012
WAVES
K111521
Waters Medical Systems, LLC
Gastroenterology & Urology · 260d
Cleared Oct 01, 2010
PERFADEX AND PERFADEX WITH THAM
K091989
Xvivo Perfusion AB
Gastroenterology & Urology · 456d
Cleared Jun 17, 2009
COSTORSOL
K091245
Preservation Solutions, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 21, 2009
COSTORSOL
K083453
Preservation Solutions, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 08, 2008
MAPERSOL
K080432
Preservation Solutions, Inc.
Gastroenterology & Urology · 171d
Cleared Jul 03, 2008
COSTORSOL
K073693
Preservation Solutions, Inc.
Gastroenterology & Urology · 185d
Cleared Oct 22, 2004
RM3 RENAL PRESERVATION SYSTEM
K042224
Waters Instruments, Inc.
Gastroenterology & Urology · 66d
Cleared Jul 31, 2003
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
K021362
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 457d
Cleared Jan 25, 2002
KPS-I, THE KIDNEY PERFUSION SOLUTION
K013575
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 10, 1999
CUSTODIOL
K992209
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 163d
Cleared Nov 04, 1999
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
K990229
Justec Medical Products, Inc.
Gastroenterology & Urology · 283d
Cleared Nov 26, 1997
BELZER-MPS
K972066
Trans-Med Corp.
Gastroenterology & Urology · 176d
Cleared Jul 29, 1997
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
K971571
Waters Instruments, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 01, 1991
K-SOL(TM)
K911587
Alcon Laboratories
Gastroenterology & Urology · 206d