Perfusion Tubing Set
FDA 510(k) K760922 · Shiley, Inc.
510(k) numberK760922
Submission
- Device name
- Perfusion Tubing Set
- Applicant
- Shiley, Inc.
Mchenry, IL, US - Received
- October 28, 1976
- Decision date
- November 19, 1976
- 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 |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
Questions and answers
When was Perfusion Tubing Set cleared by the FDA?
Perfusion Tubing Set (K760922) received a 510(k) decision of Substantially Equivalent on November 19, 1976, 22 days after the submission was received.
What is the product code of K760922?
The FDA product code is KDL – Set, Perfusion, Kidney, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5880.