Stockert Shiley Dual Pressure Control Module XR
FDA 510(k) K900797 · Shiley, Inc.
510(k) numberK900797
Submission
- Device name
- Stockert Shiley Dual Pressure Control Module XR
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- February 20, 1990
- Decision date
- May 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4310
- Specialty
- Cardiovascular
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|---|---|---|---|
| K113235 | Pressure Display Box,Dlp Disposable Pressure Display Sets-Non Sterile VersionsDXS · Special | Medtronic, Inc. | 12/02/2011SE |
| K944764 | Vti Disposable Pressure Display SetDXS · Traditional | Vascular Technology Incorporated | 12/27/1994SE |
| K912045 | TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional | Lifestream Int'L, Inc. | 10/31/1991SE |
| K873802 | Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional | American Omni Medical, Inc. | 11/06/1987SE |
| K862836 | Stockert-Shiley Caps and Caps Dual Pressure ModuleDXS · Traditional | Shiley, Inc. | 09/12/1986SE |
| K852232 | Pressure Display Box #60000/TUBING Set #61000DXS · Traditional | Dlp, Inc. | 08/09/1985SE |
| K842194 | Pressure MonitorDXS · Traditional | Norton Texas Medical Products | 08/27/1984SE |
| K831750 | PM-3DXS · Traditional | Delta Medical Industries | 07/26/1983SE |
| K822822 | Gambro Pressure Monitor PRM 10DXS · Traditional | Gambro, Inc. | 10/18/1982SE |
| K820912 | PMS-2 Pressure Monitor SeparatorDXS · Traditional | Delta Medical Industries | 05/18/1982SE |
More from Delta Medical Industries
| 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 |
| K900548 | Shiley Phonation ValveBTO · Traditional | 04/23/1990SE |
Questions and answers
When was Stockert Shiley Dual Pressure Control Module XR cleared by the FDA?
Stockert Shiley Dual Pressure Control Module XR (K900797) received a 510(k) decision of Substantially Equivalent on May 10, 1990, 79 days after the submission was received.
What is the product code of K900797?
The FDA product code is DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4310.