Stockert-Shiley Caps Battery Module
FDA 510(k) K863960 · Shiley, Inc.
510(k) numberK863960
Submission
- Device name
- Stockert-Shiley Caps Battery Module
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- October 10, 1986
- Decision date
- December 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4220
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 04/18/2023SE |
| K221373 | Essenz HLMDTQ · Traditional | Livanova Deutschland, GmbH | 03/09/2023SE |
| K210130 | Stockert S5 SystemDTQ · Special | Livanova Deutschland, GmbH | 04/05/2021SE |
| K202125 | Century Perfusion SystemDTQ · Traditional | Century Hlm, LLC | 03/07/2021SE |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ · Traditional | Spectrum Medical , Ltd. | 05/24/2019SE |
| K173834 | Quantum Pump ConsoleDTQ · Traditional | Spectrum Medical , Ltd. | 05/25/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 06/07/2017SE |
| K153376 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 12/16/2015SE |
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|---|---|---|
| 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 Stockert-Shiley Caps Battery Module cleared by the FDA?
Stockert-Shiley Caps Battery Module (K863960) received a 510(k) decision of Substantially Equivalent on December 11, 1986, 62 days after the submission was received.
What is the product code of K863960?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.