Bjork-Shiley Cardiac Heart Valve
FDA 510(k) K780772 · Shiley, Inc.
510(k) numberK780772
Submission
- Device name
- Bjork-Shiley Cardiac Heart Valve
- Applicant
- Shiley, Inc.
Mchenry, IL, US - Received
- May 4, 1978
- Decision date
- September 1, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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|---|---|---|
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| 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 Bjork-Shiley Cardiac Heart Valve cleared by the FDA?
Bjork-Shiley Cardiac Heart Valve (K780772) received a 510(k) decision of Substantially Equivalent on September 1, 1978, 120 days after the submission was received.