FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K203262 |
Bridge to Life Ltd. |
Cannula for Organ Perfusion |
07/01/2021 |
K191006 |
Bridge to Life Ltd. |
EasiSlush |
09/24/2019 |
K992209 |
DR. FRANZ KOHLER CHEMIE GMBH |
CUSTODIOL |
12/10/1999 |
K211224 |
Institut Georges Lopez |
RM4 Control Unit |
10/15/2021 |
K990229 |
JUSTEC MEDICAL PRODUCTS, INC. |
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 |
11/04/1999 |
K013575 |
ORGAN RECOVERY SYSTEMS, INC. |
KPS-I, THE KIDNEY PERFUSION SOLUTION |
01/25/2002 |
K021362 |
ORGAN RECOVERY SYSTEMS, INC. |
LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) |
07/31/2003 |
K022391 |
ORGAN RECOVERY SYSTEMS, INC. |
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION |
10/21/2002 |
K223874 |
Paragonix Technologies |
BAROguard |
08/15/2023 |
K191440 |
Paragonix Technologies |
Paragonix SherpaPak Pancreas Transport System |
12/20/2019 |
K201048 |
Paragonix Technologies |
SherpaPak Pediatric Liver Transport System |
07/02/2020 |
K143054 |
PARAGONIX TECHNOLOGIES, INC. |
Sherpa Pak Kidney Transport System |
11/25/2014 |
K133694 |
PARAGONIX TECHNOLOGIES, INC. |
SHERPA PAK TRANSPORTER |
05/23/2014 |
K192869 |
Pragonix Technologies |
SherpaPak Lung Preservation System , SherpaPak Liver Transport System |
01/16/2020 |
K073693 |
PRESERVATION SOLUTIONS, INC. |
COSTORSOL |
07/03/2008 |
K083453 |
PRESERVATION SOLUTIONS, INC. |
COSTORSOL |
01/21/2009 |
K091245 |
PRESERVATION SOLUTIONS, INC. |
COSTORSOL |
06/17/2009 |
K151728 |
PRESERVATION SOLUTIONS, INC. |
CoStorSol plus G |
09/18/2015 |
K080432 |
PRESERVATION SOLUTIONS, INC. |
MAPERSOL |
08/08/2008 |
K180481 |
S.A.L.F. spa |
Servator B SALF Solution |
06/29/2018 |
K230193 |
S.A.L.F. spa |
Servator P Plus SALF Solution |
09/21/2023 |
K202652 |
S.A.L.F. spa |
Servator P SALF Solution with THAM |
08/19/2021 |
K972066 |
TRANS-MED CORP. |
BELZER-MPS |
11/26/1997 |
K153384 |
United Therapeutics Corporation |
Low Potassium Dextran Solution with Tris Diluent |
02/19/2016 |
K042224 |
WATERS INSTRUMENTS, INC. |
RM3 RENAL PRESERVATION SYSTEM |
10/22/2004 |
K971571 |
WATERS INSTRUMENTS, INC. |
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT |
07/29/1997 |
K111521 |
WATERS MEDICAL SYSTEMS, LLC |
WAVES |
02/16/2012 |
K211333 |
XVIVO Perfusion AB |
KIDNEY ASSIST-transport |
01/20/2022 |
K091989 |
XVIVO PERFUSION AB |
PERFADEX AND PERFADEX WITH THAM |
10/01/2010 |
K170826 |
XVIVO Perfusion AB |
Perfadex Plus |
06/22/2018 |