Bio-Console, Model 560
FDA 510(k) K070286 · Medtronic
510(k) numberK070286
Submission
- Device name
- Bio-Console, Model 560
- Applicant
- Medtronic
Minneapolis, MN, US - Received
- January 29, 2007
- Decision date
- May 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWA – Control, Pump Speed, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4380
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleDWA · Special | Medtronic, Inc. | 07/24/2013SE |
| K131179 | Centrimag Primary Console (2ND Generation); Mag MonitorDWA · Special | Thoratec Corp | 07/18/2013SE |
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| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | Sorin Group Deutschland GmbH | 01/20/2011SE |
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Questions and answers
When was Bio-Console, Model 560 cleared by the FDA?
Bio-Console, Model 560 (K070286) received a 510(k) decision of Substantially Equivalent on May 22, 2007, 113 days after the submission was received.
What is the product code of K070286?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.