FDA Product Code
FDA Product Code KDL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5880
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025-01-24 | Traditional | PDF ↗ |
| K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | 2022-06-14 | Traditional | PDF ↗ |
| K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | 2022-06-14 | Traditional | PDF ↗ |
| K211842 | Servator M SALF Solution | S.A.L.F. Spa | 2021-12-20 | Traditional | PDF ↗ |
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020-04-24 | Traditional | PDF ↗ |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags | S.A.L.F. Spa | 2017-10-20 | Traditional | PDF ↗ |
| K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION | Waters Medical Systems, LLC | 2013-08-16 | Traditional | PDF ↗ |
| K121618 | BEL-GEN COLD STORAGE SOLUTION | Waters Medical Systems, LLC | 2013-06-14 | Traditional | PDF ↗ |
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | Organ Recovery Systems, Inc. | 2010-03-11 | Traditional | PDF ↗ |
| K043461 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2005-02-28 | Traditional | PDF ↗ |
| K020924 | CUSTODIOL HTK SOLUTION | Dr. Franz Kohler Chemie GmbH | 2003-01-06 | Traditional | PDF ↗ |
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | Cobe Renal Care, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K944866 | VIASPAN (BELZER UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996-04-22 | Traditional | PDF ↗ |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | The DU Pont Co. | 1990-03-20 | Traditional | PDF ↗ |
| K891239 | MOP CATHETER | Bivona Medical Technologies | 1989-11-28 | Traditional | PDF ↗ |
| K883782 | BELZER UW-CSS | Du Pont Critical Care | 1989-04-20 | Traditional | PDF ↗ |
| K884609 | EURO-COLLINS SOLUTION SETS | Fresenius USA, Inc. | 1989-01-26 | Traditional | PDF ↗ |
| K780470 | H.P. MEDICAL GRADE SILICONE TUBING | Dow Corning Corp. Healthcare Industries Materials | 1978-04-27 | Traditional | PDF ↗ |
| K760922 | PERFUSION TUBING SET | Shiley, Inc. | 1976-11-19 | Traditional | PDF ↗ |
Product code KDL · Class II · Gastroenterology, Urology. Data: openFDA.