Labeling Change - Viaspan(Tm) (Belzer Uw)
FDA 510(k) K900492 · The DU Pont Co.
510(k) numberK900492
Submission
- Device name
- Labeling Change - Viaspan(Tm) (Belzer Uw)
- Applicant
- The DU Pont Co.
Wilmington, DE, US - Received
- February 2, 1990
- Decision date
- March 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDL – Set, Perfusion, Kidney, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5880
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KDL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241239 | OrganProtex HTK SolutionKDL · Traditional | Bridge TO Life, Ltd. | 01/24/2025SE |
| K221387 | BEL-GEN Cold Storage SolutionKDL · Traditional | Institut Georges Lopez | 06/14/2022SE |
| K221386 | PERF-GEN Pulsatile Perfusion SolutionKDL · Traditional | Institut Georges Lopez | 06/14/2022SE |
| K211842 | Servator M SALF SolutionKDL · Traditional | S.A.L.F. Spa | 12/20/2021SE |
| K192408 | Custodiol HTK SolutionKDL · Traditional | Dr. Franz Kohler Chemie GmbH | 04/24/2020SE |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC…KDL · Traditional | S.A.L.F. Spa | 10/20/2017SE |
| K121736 | Perf-Gen Pulsatile Perfusion SolutionKDL · Traditional | Waters Medical Systems, LLC | 08/16/2013SE |
| K121618 | Bel-Gen Cold Storage SolutionKDL · Traditional | Waters Medical Systems, LLC | 06/14/2013SE |
| K091656 | SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2LKDL · Traditional | Organ Recovery Systems, Inc. | 03/11/2010SE |
| K043461 | CustodiolKDL · Traditional | Dr. Franz Kohler Chemie GmbH | 02/28/2005SE |
More from Dr. Franz Kohler Chemie GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K953477 | Modular Daylight Cassette for Video ImagingLMC · Traditional | 10/07/1995SE |
| K953475 | CDS Compact Daylight Cassette for Video ImagingLMC · Traditional | 10/07/1995SE |
| K952891 | Cronex Low Absorption CassetteIXA · Traditional | 07/13/1995SE |
| K945125 | Dupont Aca Vancomycin (Vanc) MethodLEH · Traditional | 03/10/1995SE |
| K943704 | Lipase CalibratorJIT · Traditional | 09/14/1994SE |
| K885259 | Aca Thyronine Uptake (Tu E) MethodKHQ · Traditional | 02/17/1989SE |
| K885258 | Aca Thyroxine (T4 E) MethodKLI · Traditional | 02/17/1989SE |
| K884700 | Analyst Thyroxine (T4) RotorKLI · Traditional | 01/27/1989SE |
| K884169 | Du Pont Analyst Thyroid RotorCEL · Traditional | 01/24/1989SE |
| K884168 | Analyst Thyroxine (T4) & Thyronine Uptake Calibra.JIS · Traditional | 11/29/1988SE |
Questions and answers
When was Labeling Change - Viaspan(Tm) (Belzer Uw) cleared by the FDA?
Labeling Change - Viaspan(Tm) (Belzer Uw) (K900492) received a 510(k) decision of Substantially Equivalent on March 20, 1990, 46 days after the submission was received.
What is the product code of K900492?
The FDA product code is KDL – Set, Perfusion, Kidney, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5880.