KDL · Set, Perfusion, Kidney, Disposable
Gastroenterology, Urology · 21 CFR 876.5880 · Class 2
Overview
| Product Code | KDL |
|---|---|
| Device Name | Set, Perfusion, Kidney, Disposable |
| Regulation | 21 CFR 876.5880 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | Jan 24, 2025 | SESE |
| K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | Jun 14, 2022 | SESE |
| K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | Jun 14, 2022 | SESE |
| K211842 | Servator M SALF Solution | S.A.L.F. Spa | Dec 20, 2021 | SESE |
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | Apr 24, 2020 | SESE |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags | S.A.L.F. Spa | Oct 20, 2017 | SESE |
| K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION | Waters Medical Systems, LLC | Aug 16, 2013 | SESE |
| K121618 | BEL-GEN COLD STORAGE SOLUTION | Waters Medical Systems, LLC | Jun 14, 2013 | SESE |
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | Organ Recovery Systems, Inc. | Mar 11, 2010 | SESE |
| K043461 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | Feb 28, 2005 | SESE |
| K020924 | CUSTODIOL HTK SOLUTION | Dr. Franz Kohler Chemie GmbH | Jan 6, 2003 | SESE |
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | Cobe Renal Care, Inc. | Sep 25, 1997 | SESE |
| K944866 | VIASPAN (BELZER UW - CSS) | The Dupont Merck Pharmaceutical Co. | Apr 22, 1996 | SESE |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | The DU Pont Co. | Mar 20, 1990 | SESE |
| K891239 | MOP CATHETER | Bivona Medical Technologies | Nov 28, 1989 | SESE |
| K883782 | BELZER UW-CSS | Du Pont Critical Care | Apr 20, 1989 | SESE |
| K884609 | EURO-COLLINS SOLUTION SETS | Fresenius USA, Inc. | Jan 26, 1989 | SESE |
| K780470 | H.P. MEDICAL GRADE SILICONE TUBING | Dow Corning Corp. Healthcare Industries Materials | Apr 27, 1978 | SESE |
| K760922 | PERFUSION TUBING SET | Shiley, Inc. | Nov 19, 1976 | SESE |
Top Applicants
- Dr. Franz Kohler Chemie GmbH — 3 clearances
- Institut Georges Lopez — 2 clearances
- S.A.L.F. Spa — 2 clearances
- Waters Medical Systems, LLC — 2 clearances
- Bivona Medical Technologies — 1 clearance
