Bio-Console 560
FDA 510(k) K080824 · Medtronic Perfusion Systems
510(k) numberK080824
Submission
- Device name
- Bio-Console 560
- Applicant
- Medtronic Perfusion Systems
Minneapolis, MN, US - Received
- March 24, 2008
- Decision date
- May 7, 2008
- 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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| K191557 | CentriMag Acute Circulatory Support SystemDWA · Special | Thoratec Corporation (Now Part of Abbott) | 07/10/2019SE |
| K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleDWA · Special | Medtronic, Inc. | 07/24/2013SE |
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| K090869 | Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…DWF · Traditional | 08/27/2009SE |
| K061254 | Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222DWF · Special | 06/23/2006SE |
| K052524 | Bio-Medicus Multi-Stage Venous Femoral Percutaneous KitDWF · Special | 11/22/2005SE |
| K052372 | MC2X Multi-Stage Venous Cannula, Models 91437, 91437CDWF · Special | 09/22/2005SE |
| K051303 | Bio-Console, Model 560DWA · Special | 06/10/2005SE |
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Questions and answers
When was Bio-Console 560 cleared by the FDA?
Bio-Console 560 (K080824) received a 510(k) decision of Substantially Equivalent on May 7, 2008, 44 days after the submission was received.
What is the product code of K080824?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.