Schneider-Shiley Y-Connector with Rotator
FDA 510(k) K862464 · Shiley, Inc.
510(k) numberK862464
Submission
- Device name
- Schneider-Shiley Y-Connector with Rotator
- Applicant
- Shiley, Inc.
Irvine, CA, US - Received
- June 30, 1986
- Decision date
- August 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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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 |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
Questions and answers
When was Schneider-Shiley Y-Connector with Rotator cleared by the FDA?
Schneider-Shiley Y-Connector with Rotator (K862464) received a 510(k) decision of Substantially Equivalent on August 28, 1986, 59 days after the submission was received.
What is the product code of K862464?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.