Stockert-Shiley Caps Timer Module
FDA 510(k) K862973 · Shiley, Inc.
510(k) numberK862973
Submission
- Device name
- Stockert-Shiley Caps Timer Module
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- August 6, 1986
- Decision date
- October 1, 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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| K221373 | Essenz HLMDTQ · Traditional | Livanova Deutschland, GmbH | 03/09/2023SE |
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| K153376 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 12/16/2015SE |
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| 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 |
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Questions and answers
When was Stockert-Shiley Caps Timer Module cleared by the FDA?
Stockert-Shiley Caps Timer Module (K862973) received a 510(k) decision of Substantially Equivalent on October 1, 1986, 56 days after the submission was received.
What is the product code of K862973?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.