KDL — Set, Perfusion, Kidney, Disposable Class II
FDA product code KDL covers "Set, Perfusion, Kidney, Disposable", a Class II medical device regulated under 21 CFR 876.5880. Submissions are reviewed by the Gastroenterology, Urology panel. At least 19 recent 510(k) clearances have been granted under this product code.
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 |