KDL — Set, Perfusion, Kidney, Disposable Class II
FDA Device Classification
Classification Details
- Product Code
- KDL
- Device Class
- Class II
- Regulation Number
- 876.5880
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K241239 | bridge to life | OrganProtex HTK Solution | January 24, 2025 |
| K221387 | institut georges lopez | BEL-GEN Cold Storage Solution | June 14, 2022 |
| K221386 | institut georges lopez | PERF-GEN Pulsatile Perfusion Solution | June 14, 2022 |
| K211842 | s.a.l.f | Servator M SALF Solution | December 20, 2021 |
| K192408 | franz kohler chemie | Custodiol HTK Solution | April 24, 2020 |
| K170150 | s.a.l.f | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml | October 20, 2017 |
| K121736 | waters medical systems | PERF-GEN PULSATILE PERFUSION SOLUTION | August 16, 2013 |
| K121618 | waters medical systems | BEL-GEN COLD STORAGE SOLUTION | June 14, 2013 |
| K091656 | organ recovery systems | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | March 11, 2010 |
| K043461 | franz kohler chemie | CUSTODIOL | February 28, 2005 |
| K020924 | franz kohler chemie | CUSTODIOL HTK SOLUTION | January 6, 2003 |
| K955497 | cobe renal care | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | September 25, 1997 |
| K944866 | dupont merck pharmaceutical | VIASPAN (BELZER UW - CSS) | April 22, 1996 |
| K900492 | du pont | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | March 20, 1990 |
| K891239 | bivona medical technologies | MOP CATHETER | November 28, 1989 |
| K883782 | du pont critical care | BELZER UW-CSS | April 20, 1989 |
| K884609 | fresenius usa | EURO-COLLINS SOLUTION SETS | January 26, 1989 |
| K780470 | dow corning corp. healthcare industries materials | H.P. MEDICAL GRADE SILICONE TUBING | April 27, 1978 |
| K760922 | shiley | PERFUSION TUBING SET | November 19, 1976 |