Modified Stockert-Shiley Caps Multi. Roller Pump
FDA 510(k) K890904 · Shiley, Inc.
510(k) numberK890904
Submission
- Device name
- Modified Stockert-Shiley Caps Multi. Roller Pump
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- February 10, 1989
- Decision date
- April 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4370
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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|---|---|---|---|
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | Terumo Cardiovascular Systems Corporation | 11/17/2016SE |
| K131618 | Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for…DWB · Traditional | Terumo Cardiovascular Systems Corporation | 09/27/2013SE |
| K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,DWB · Traditional | Terumo Cardiovascular Systems Corp. | 12/19/2011SE |
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | Medtronic Bio-Medicus, Inc. | 04/27/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | Stoeckert Instrumente | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | Stoeckert Instrumente | 09/10/1997SE |
| K960974 | Cobe Century Perfusion PumpDWB · Traditional | Cobe Cardiovascular, Inc. | 07/14/1997SE |
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 3M Health Care, Ltd. | 04/19/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 3M Health Care, Sarns | 04/19/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | Stoeckert Instrumente | 02/21/1996SE |
More from Stoeckert Instrumente
| 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 Modified Stockert-Shiley Caps Multi. Roller Pump cleared by the FDA?
Modified Stockert-Shiley Caps Multi. Roller Pump (K890904) received a 510(k) decision of Substantially Equivalent on April 12, 1989, 61 days after the submission was received.
What is the product code of K890904?
The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.