510(k) K020924
- Device
- CUSTODIOL HTK SOLUTION
- Applicant
- DR. FRANZ KOHLER CHEMIE GMBH
- 510(k) number
- K020924
- Product code
- KDL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-06
- Date received
- 2002-03-21
- Regulation
- 876.5880
- Classification name
- Set, Perfusion, Kidney, Disposable
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- T. WHIT ATHEY
- Address
- 2305 Gold Mine Rd. Brookeville MD US 20833 20833
FDA Registration Numbers#
- 3007685782
- 3020224798
- 3003708554
- 3017298490
- 9615922
- 3010680515
- 3031884833
- 3004068499
- 3011292417
- 1067143
- 3024820181
- 3010765841
- 2123774
- 3011421726
Source Documents#
Other 510(k) Records For Product Code KDL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025-01-24 |
| K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | 2022-06-14 |
| K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | 2022-06-14 |
| K211842 | Servator M SALF Solution | S.A.L.F. Spa | 2021-12-20 |
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020-04-24 |
| 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 |
| K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION | Waters Medical Systems, LLC | 2013-08-16 |
| K121618 | BEL-GEN COLD STORAGE SOLUTION | Waters Medical Systems, LLC | 2013-06-14 |
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | Organ Recovery Systems, Inc. | 2010-03-11 |
| K043461 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2005-02-28 |
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | Cobe Renal Care, Inc. | 1997-09-25 |
| K944866 | VIASPAN (BELZER UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996-04-22 |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | The DU Pont Co. | 1990-03-20 |
| K891239 | MOP CATHETER | Bivona Medical Technologies | 1989-11-28 |
| K883782 | BELZER UW-CSS | Du Pont Critical Care | 1989-04-20 |
Legacy Summary#
summary
FDA Review#
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