FDA 510(k) Applications for Medical Device Product Code "KDL"
(Set, Perfusion, Kidney, Disposable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K955497 | COBE RENAL CARE, INC. | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | 09/25/1997 |
| K043461 | DR. FRANZ KOHLER CHEMIE GMBH | CUSTODIOL | 02/28/2005 |
| K020924 | DR. FRANZ KOHLER CHEMIE GMBH | CUSTODIOL HTK SOLUTION | 01/06/2003 |
| K192408 | Dr. Franz Kohler Chemie GmbH | Custodiol HTK Solution | 04/24/2020 |
| K221387 | Institut Georges Lopez | BEL-GEN Cold Storage Solution | 06/14/2022 |
| K221386 | Institut Georges Lopez | PERF-GEN Pulsatile Perfusion Solution | 06/14/2022 |
| K091656 | ORGAN RECOVERY SYSTEMS, INC. | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | 03/11/2010 |
| K170150 | S.A.L.F. spa | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags | 10/20/2017 |
| K211842 | S.A.L.F. spa | Servator M SALF Solution | 12/20/2021 |
| K944866 | THE DUPONT MERCK PHARMACEUTICAL CO. | VIASPAN (BELZER UW - CSS) | 04/22/1996 |
| K121618 | WATERS MEDICAL SYSTEMS, LLC | BEL-GEN COLD STORAGE SOLUTION | 06/14/2013 |
| K121736 | WATERS MEDICAL SYSTEMS, LLC | PERF-GEN PULSATILE PERFUSION SOLUTION | 08/16/2013 |
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